Systems and methods for performing image guided procedures within the ear, nose, throat and paranasal sinuses

ABSTRACT

Devices, systems and methods for performing image guided interventional and surgical procedures, including various procedures to treat sinusitis and other disorders of the paranasal sinuses, ears, nose or throat.

RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/116,118 entitled “Methods And Devices For Performing ImageGuided Procedures Within The Ear, Nose, Throat And Paranasal Sinuses”filed Apr. 26, 2005 which is a continuation in part of fourearlier-filed applications, namely 1) U.S. patent application Ser. No.10/829,917 entitled “Devices, Systems and Methods for Diagnosing andTreating Sinusitis and Other Disorders of the Ears, Nose and/or Throat”filed on Apr. 21, 2004, 2) U.S. patent application Ser. No. 10/912,578entitled “Implantable Device and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders” filed on Aug. 4,2004, 3) U.S. patent application Ser. No. 10/944,270 entitled “Apparatusand Methods for Dilating and Modifying Ostia of Paranasal Sinuses andOther Intranasal or Paranasal Structures” filed on Sep. 17, 2004 and 4)U.S. patent application Ser. No. 11/037,548 entitled “Devices, Systemsand Methods For Treating Disorders of the Ear, Nose and Throat” filedJan. 17, 2005, the entireties of each such parent application beingexpressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods and more particularly to methods and devices for performingimage guided interventional procedures to treat disorders of theparanasal sinuses, ears, nose or throat (ENT).

BACKGROUND OF THE INVENTION

A. Recent Advancements in the Treatment of ENT Disorders

New devices, systems and techniques are being developed for thetreatment of sinusitis and other disorders of the ear, nose, throat andparanasal sinuses. For example, various catheters, guidewires and otherdevices useable to perform minimally invasive, minimally traumatic ear,nose and throat surgery have been described in U.S. patent applicationsSer. No. 10/829,917 entitled “Devices, Systems and Methods forDiagnosing and Treating Sinusitis and Other Disorders of the Ears, Noseand/or Throat,” Ser. No. 10/912,578 entitled “Implantable Device andMethods for Delivering Drugs and Other Substances to Treat Sinusitis andOther Disorders,” Ser. No. 10/944,270 entitled “Apparatus and Methodsfor Dilating and Modifying Ostia of Paranasal Sinuses and OtherIntranasal or Paranasal Structures” and Ser. No. 11/037,548 entitled“Devices, Systems and Methods For Treating Disorders of the Ear, Noseand Throat.” Many of these new devices, systems and techniques areuseable in conjunction with endoscopic, radiographic and/or electronicassistance to facilitate precise positioning and movement of catheters,guidwires and other devices within the ear, nose, throat and paranasalsinuses and to avoid undesirable trauma or damage to critical anatomicalstructures such as the eyes, facial nerves and brain.

For example, in one new procedure (referred to in this patentapplication as a “Flexible Transnasal Sinus Intervention” or FTSI), adilation catheter (e.g., a balloon catheter or other type of dilator) isadvanced through the nose to a position within the ostium of a paranasalsinus or other location, without requiring removal or surgicalalteration of other intranasal anatomical structures. The dilationcatheter is then used to dilate the ostium or other anatomicalstructures to facilitate natural drainage from the sinus cavity. In somecases, a tubular guide may be initially inserted through the nose andadvanced to a position near the sinus ostium and a guidewire may then beadvanced through the tubular guide and into the affected paranasalsinus. The dilation catheter may then be advanced over the guidewire andthrough the tubular guide to a position where its dilator (e.g.,balloon) is positioned within the sinus ostium. The dilator (e.g.,balloon) is then expanded causing the ostium to dilate. In some cases,such dilation of the ostium may fracture, move or remodel bonystructures that surround or are adjacent to the ostium. Optionally, insome procedures, irrigation solution and/or therapeutic agents may beinfused through a lumen of the dilation catheter and/or other workingdevices (e.g., guidewires, catheters, cannula, tubes, dilators,balloons, substance injectors, needles, penetrators, cutters, debriders,microdebriders, hemostatic devices, cautery devices, cryosurgicaldevices, heaters, coolers, scopes, endoscopes, light guides,phototherapy devices, drills, rasps, saws, etc.) may be advanced throughthe tubular guide and/or over the guidewire to deliver other therapy tothe sinus or adjacent tissues during the same procedure in which theFTSI is carried out. It is to be understood that, in FTSI procedures,structures and passageways other than sinus ostia may be dilated usingthe tools described above, tissue may be resected or ablated, bone maybe restructured, drugs or drug delivery systems may be deployed, etc.,as described in the documents incorporated here by reference. Thus, forthe purposes of this application the term FTSI will generally used torefer broadly to all of those procedures, not just dilation of sinusostia.

B. Prior Uses of Image Guided Surgery in the Treatment of ENT Disorders

Image guided surgery (IGS) procedures (sometimes referred to as“computer assisted surgery”) were first developed for use inneurosurgery and have now been adapted for use in certain ENT surgeries,including sinus surgeries. See, Kingdom T. T., Orlandi R. R.,Image-Guided Surgery of the Sinuses: Current Technology andApplications, Otolaryngol. Clin. North Am. 37(2):381-400 (April 2004).Generally speaking, in a typical IGS procedure, a digital tomographicscan (e.g., a CT or MRI scan) of the operative field (e.g., the nasalcavities and paranasal sinuses) is obtained prior to surgery. Aspecially programmed computer is then used to convert the digitaltomographic scan data into a digital map. During surgery, sensorsmounted on the surgical instruments send data to the computer indicatingthe position of each surgical instrument. The computer correlates thedata received from the instrument-mounted sensors with the digital mapthat was created from the preoperative tomographic scan. One or moreimage(s) is/are then displayed on a monitor showing the tomographic scanalong with an indicator (e.g., cross hairs or an illuminated dot) of thereal time position of each surgical instrument. In this manner, thesurgeon is able to view the precise position of each sensor-equippedinstrument relative to the surrounding anatomical structures shown onthe tomographic scan.

A typical IGS surgery system of the prior art includes a) a computerwork station, b) a video monitor, c) one or more surgical instrumentshaving sensors mounted thereon, d) a localizer and e) a sensor trackingsystem. The sensor(s) mounted on the surgical instruments and thecorresponding tracing system may be optical, electromagnetic orelectromechanical. The localizer functions to localize or “register” thepreoperative tomographic image data with the real time physicalpositioning of the patient's body during surgery. The sensor trackingsystem serves to track the position of each sensor equipped surgicalinstrument during the surgery and to communicate such information to thecomputer workstation.

In IGS systems that employ optical sensors/tracking systems, opticalnavigation elements (e.g., infrared light emitting LEDs or passivemarkers) are placed on the surgical instruments and on a localizer frameworn by the patient. Camera(s) is/are positioned to receive lightemitted or reflected from the navigation elements. One example of anoptical IGS system that is useable in ENT and sinus surgery is theLandmarX Evolutions ENT II Image Guidance System available fromMedtronic Xomed Surgical Products, Inc., Jacksonville, Fla. Otheroptical IGS systems useable in ENT surgery include the VectorVision®system and Kolibri® system available from BrainLAB, Inc., Westchester,Ill. In the VectorVision® system and Kolibri® systems a sensor assembly,known as a STARLINK™ Universal Instrument Adapter, is attached to aportion of an instrument that remains outside of the patients body. Aplurality of passive markers in the nature of reflective members ispositioned at spaced apart locations on the navigation element assembly.An infrared light source and cameras are positioned to receive lightreflected from the passive markers located on the navigation elementassembly. A computer then receives input from the cameras and usessoftware tracking algorithms to determine the real time position of theinstrument within the subject's body based on the relative spatialpositions of the passive markers. The instrument's current position isthen displayed on a monitor along with stored tomographic images,thereby enabling the operator to monitor the position and movement ofthe instrument relative to anatomical structures of interest.

In IGS systems that employ electromagnetic sensors/tracking systems,radiofrequency electromagnetic sensors (e.g., electromagnetic coils) areplaced on the surgical instruments and on a localizer frame worn by thepatient. A transmitter is positioned near the operative field. Thetransmitter transmits signals that are received by theinstrument-mounted sensors. The tracking system detects variations inthe electromagnetic field caused by the movement of theinstrument-mounted sensors relative to the transmitter. Examples ofcommercially available electromagnetic IGS systems that have been usedin ENT and sinus surgery include the ENTrak plus™ and InstaTrak ENT™systems available from GE Medical Systems, Salt Lake City, Utah. Otherexamples of electromagnetic image guidance systems that may be modifiedfor use in accordance with the present invention include but are notlimited to those available from Surgical Navigation Technologies, Inc.,Louiville, Colo., Biosense-Webster, Inc., Diamond Bar, Calif. andCalypso Medical Technologies, Inc., Seattle, Wash.

In IGS systems that employ electromechanical sensors/tracking systems, amulti-jointed articulating mechanical arm is attached to the surgicalinstrument and sensors to measure movements of the joints. The computerdetermines the location of the instrument based on signals received fromthe sensors. Electromechanical systems have not been widely used in ENTor sinus surgery.

In any IGS system used in sinus surgery or other ENT applications, it isimperative that the localization system provide accurate “registration.”Registration is the process of matching two sets of data (i.e., thepreoperative tomographic scan data and the intraoperative patient bodyposition data) so that the image displayed on the monitor willaccurately show the position(s) of the surgical instrument(s) relativeto the locations of anatomical structures shown on the tomographic scan.A number of different registration strategies have been used, includingintrinsic strategies as well as extrinsic strategies.

The registration strategy most widely used in sinus surgery and otherENT procedures is an intrinsic registration strategy known as anatomicalfiducial registration. A number of fiducial markers are placed atspecific anatomical locations on the patient's body during thepreoperative tomographic scan and during the surgical procedure. Thesefiducial markers are typically positioned on the patient's head or faceat locations that correspond to specific anatomical landmarks within theears, nose and/or throat. The fiducial markers may be mounted on a headset or frame that is worn by the patient or the fiducial markers may beaffixed directly to the patient's body (e.g., by adhesive attachment tothe skin, anchoring into bone, etc.).

Once the registration process has been completed, the sinus surgery orother ENT procedure is performed. To correlate head position with thetracking system, the fiducial markers must remain in fixed position onor in the patient's body until after the surgery has been completed.Unlike neurosurgical procedures that require the patient's head to befixed in a rigid stereotactic frame, IGS systems that use fiducialmarkers mounted on or in the patient's body allow for free movement andrepositioning of the patient's head during surgery.

When applied to functional endoscopic sinus surgery (FESS) the use ofimage guidance systems allows the surgeon to achieve more precisemovement and positioning of the surgical instruments than can beachieved by viewing through an endoscope alone. This is so because atypical endoscopic image is a spatially limited, two dimensional,line-of-sight view. The use of image guidance systems provides a realtime, three dimensional view of all of the anatomy surrounding theoperative field, not just that which is actually visible in thespatially limited, two dimensional, direct line-of-sight endoscopicview.

One shortcoming of the prior art IGS systems used in sinus surgery andother ENT procedures is that the sensors have been mounted on proximalportions of the instruments (e.g., on the handpiece of the instrument)such that the sensors remain outside of the patient's body during thesurgical procedure. Because these prior art surgical instruments were ofrigid, pre-shaped construction, the proximally mounted sensors could beused to accurately indicate to real time position of the distal tip ofthe instrument. However, in the new FTSI procedures and other new ENTprocedures that use flexible and/or malleable catheters and instruments,it is no longer suitable to mount the sensors on proximal portions ofthe surgical instruments such that the sensors remain outside of thebody. Rather, it will be necessary to mount or integrate the sensors atthe distal tips of the instruments and/or at other locations on portionsof the instruments that are actually inserted into the patient's body,thereby allowing for flexibility or malleability of the instrumentshaft.

The present invention provides new sensor-equipped devices that areuseable to perform image guided FTSI procedures as well as a variety ofother image guided ENT procedures. Additionally, the present inventionprovides improvements and modifications to the prior art IGS systems andmethods to facilitate the performance of image guided FTSI and otherimage ENT procedures with minimal or less iatrogenic trauma to and/oralteration of anatomical structures that are not involved in thedisorder being treated.

SUMMARY OF THE INVENTION

The present invention generally provides methods, systems and devicesfor performing image guided FTSI procedures as well as other imageguided procedures for the treatment of sinusitis and other disorders ofthe paranasal sinuses, ears, nose and/or throat.

In accordance with the invention, there is provided a method and systemfor performing an image guided treatment procedure to treat a disease ordisorder of an ear, nose, throat or a paranasal sinus in a human oranimal subject. In this method and system, a working device (e.g.,guidewires, catheters, cannula, tubes, dilators, balloons, substanceinjectors, needles, penetrators, cutters, debriders, microdebriders,hemostatic devices, cautery devices, cryosurgical devices, heaters,coolers, scopes, endoscopes, light guides, phototherapy devices, drills,rasps, saws, etc.) is inserted into an ear, nose, throat or paranasalsinus of the subject and used to carry out or facilitate at least aportion of the treatment procedure. A sensor is positioned on or in theportion of the working device that becomes inserted into the ear, nose,throat or paranasal sinus of the subject. An image guidance system isused to determine the location of the sensor when the sensor ispositioned within an ear, nose, throat or paranasal sinus of thesubject, thereby providing a real time indication of the positioning andmovement of the working device during the treatment procedure. In someapplications, a preoperative tomographic scan (e.g., a CT scan, MRIscan, PET scan, 3 dimensional fluoroscopy such as FluoroCT, etc.) may beobtained and the image guidance system may be programmed to display thetomographic images on a video monitor along with a real time indication(e.g., cross hairs, an illuminated dot, etc.) of the location of theworking device relative to the anatomical structures shown on thetomographic image. In some embodiments, an endoscope or intranasalcamera may additionally be used to provide a direct line-of-sight videoimage through the nasal cavity. Such direct line-of-sight video imagemay be displayed on a separate monitor or may be integrated with thetomographic image data to provide a single monitor display combining 1)the real time line-of-sight video image, 2) indicia (e.g., dotted lines)depicting anatomical structures that are hidden from view on the realtime line-of-sight video image and 3) indicia of instrument positionprovided by the image guidance system. In some applications, the indiciaof instrument position may consist of a single indicator (e.g., crosshairs or a dot) indicating the current position of the working devicewithin the subject's body. In other applications, the indicia ofinstrument position may consist of a series of marks (e.g., a sharp dotfollowed by a series of phantom dots) indicating the path of prior orfuture advancement or movement of the working device. Also, in someapplications, the working device may optionally include a rotationindicator (e.g., an accelerometer) and the image guidance system may befurther programmed to sense and indicate the rotational orientation ofthe working device within the subject's body.

Further in accordance with the invention, there are providedsensor-equipped working devices (e.g., guidewires, catheters, cannula,tubes, dilators, balloons, substance injectors, needles, penetrators,cutters, debriders, microdebriders, hemostatic devices, cautery devices,cryosurgical devices, heaters, coolers, scopes, endoscopes, lightguides, phototherapy devices, drills, rasps, saws, etc.) useable toperform image guided FTSI procedures or other image guided ENTprocedures. These image guided working devices of the present inventiongenerally comprise an elongate shaft that is insertable through the noseto a location within a paranasal sinus, ear, nose or throat of thesubject and one or more sensor(s) is/are positioned on or in the deviceat a location that becomes inserted into the subject's body during theprocedure. In some embodiments, a sensor may be located at the distaltip of the device. Additionally or alternatively, sensor(s) may belocated at other locations on the shaft of the device, such as at thelocation of a particular working element (e.g., a dilator, balloon,substance injector, needle, penetrator, cutter, debrider, microdebrider,hemostatic device, cautery device, cryosurgical device, heater, cooler,scope, lense, port, endoscope, light guide, phototherapy device, drill,rasp, saw, etc.). In some embodiments, the shaft of the working deviceproximal to the sensor(s) may be flexible or malleable. Such flexibilityor malleability may allow the working device to be advanced thoughtortuous regions of the intra nasal anatomy and/or to be positionedbehind obstructive anatomical structure(s) (e.g., behind the uncinateprocess) without traumatizing or requiring removal or surgicalmodification of the obstructive anatomical structure(s).

Still further in accordance with the present invention, there isprovided a system of working devices specifically useable to perform animage guided FTSI procedure. Such system generally comprises a flexibleguidewire that is advanceable into the ostium of a paranasal sinus and adilation catheter that is advanceable over the guidewire and useable todilate the ostium of the paranasal sinus. A sensor is located on aportion of the guidewire and/or dilation catheter that becomespositioned within the subject's body. The sensor communicates with theimage guidance system to provide real time indicia of the position ofthe guidewire and/or dilation catheter such that the operator mayprecisely position the dilator within the desired sinus ostium withoutthe need for obtaining direct line-of-sight endoscope view of that sinusostium. Optionally, the system may additionally comprise a tubular guidethrough which the guidewire and/or dilation catheter may be advanced.The tubular guide may be rigid, flexible or malleable and may bespecifically configured to be advanced through the nose to a positionwithin or near the ostium of the affected paranasal sinus.

Still further in accordance with the present invention, there areprovided fiducial marker devices that may be precisely and reproduciblypositioned within the mouth of a human subject. In some embodiments,these fiducial marker devices may incorporate brackets, projection ofother configurational attributes for mounting of a transmitter useablein conjunction with an electromagnetic image guidance system.

Still further in accordance with the present invention there areprovided methods and systems for image guided procedures wherein asingle sensor is mounted on a working device that is inserted into thebody (e.g., into a paranasal sinus, and a plurality of transmitters arepositioned outside of the subject's body such that the device-mountedsensor will receive signals from at least 3 transmitters, therebyenabling a computer within the image guidance system to compute (e.g.,triangulate) the three dimensional position of the sensor within thesubject's body.

Still further in accordance with the present invention there is provideda system that is useable to perform a procedure in which a workingdevice is inserted to a position within an ear, nose, throat orparanasal sinus of a human or animal subject. In general, such systemcomprises a) a working device that has a proximal end and a distal end,said working device being insertable into an ear, nose, throat orparanasal sinus of a human or animal subject and useable to facilitateperformance of a diagnostic or therapeutic procedure; b) an extenderthat is attachable to the proximal end of the working device; c) amarker assembly that is attachable to or part of the extender, saidmarker assembly comprising a plurality of active or passive markers; andd) an image guidance system that is adapted to receive signals from thesensors and to determine, on the basis of said signals, the currentposition of the working device within the subject's body. In someembodiments, the working device may have a lumen through which a secondworking device may be inserted or through which a fluid or substance maybe infused. In such embodiments, the extender may also have a lumen thatbecomes substantially continuous with the working device lumen tofacilitate delivery of such second working device or substance. In someembodiments, the marker assembly may be attachable to and detachablefrom the extender by way of a clamp or other connector apparatus. Stillfurther in accordance with the invention, there is provided a method forimage guided performance of a treatment procedure to treat a disease ordisorder of an ear, nose, throat or a paranasal sinus in a human oranimal subject. Such method generally comprises the steps of a)providing a working device that is useable to carry out or facilitate atleast a portion of said treatment procedure, said working device havinga distal end that becomes inserted into the subject's body and aproximal end that remains outside of the subjects body; b) providing anextension member that is attachable to the proximal end of the workingdevice; c) providing a marker assembly that comprises a plurality ofmarkers, said marker assembly being attachable to the extension member;c) providing an image guidance system that is useable to determine thelocation of the working device within the ear, nose, throat or paranasalsinus of the subject on the basis of signals received from the markersof the marker assembly; d) attaching the extension member to theproximal end of the working device; e) attaching the marker assembly tothe extension member; g) inserting the distal end of the working deviceinto the subject's body; and h) using the image guidance system todetect the position of the working device within the subject's body onthe basis of signals received from the markers of the marker assembly.

Further aspects, details and embodiments of the present invention willbe understood by those of skill in the art upon reading the followingdetailed description of the invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a sensor-equipped guidewire of the presentinvention.

FIG. 1A is an enlarged cut-away view of the distal end of thesensor-equipped guidewire of FIG. 1.

FIG. 2A is a perspective view of a sensor-equipped guide tube of thepresent invention.

FIG. 2B is a perspective view of another sensor-equipped guide tube ofthe present invention.

FIG. 3 is a schematic perspective view of a sensor-equipped workingdevice useable to perform a therapeutic or diagnostic procedure withinan ear, nose, throat or paranasal sinus.

FIG. 4 is a perspective view of a sensor-equipped dilation catheter ofthe present invention.

FIG. 4A is a partial cut away view of a first embodiment of a sensorequipped balloon dilation catheter of the present invention.

FIG. 4B is a cross sectional view through line 4B-4B of FIG. 4A.

FIG. 4C is a partial cut away view of a second embodiment of a sensorequipped balloon dilation catheter of the present invention.

FIG. 4D is a cross sectional view through line 4D-4D of FIG. 4C.

FIG. 4E is a partial cut away view of a third embodiment of a sensorequipped balloon dilation catheter of the present invention.

FIG. 4F is a cross sectional view through line 4F-4F of FIG. 4E.

FIG. 4G is a partial cut away view of a fourth embodiment of a sensorequipped balloon dilation catheter of the present invention.

FIG. 4H is a cross sectional view through line 4H-4H of FIG. 4G.

FIG. 4I is a partial cut away view of a fifth embodiment of a sensorequipped balloon dilation catheter of the present invention.

FIG. 4J is a cross sectional view through line 4J-4J of FIG. 4I.

FIG. 5 is a perspective view of a sensor-equipped sub-selective sheathof the present invention.

FIG. 5A is a cross sectional view through line 5A-5A of FIG. 5.

FIG. 6 is a side view of a sensor equipped penetrator of the presentinvention.

FIG. 7A shows a human subject undergoing a preoperative tomographic scanwhile wearing a head frame having fiducial anatomical markers thereon.

FIG. 7B is a schematic showing of data from the preoperative tomographicscan being loaded into the computer workstation of the image guidancesystem in accordance with this invention.

FIG. 7C shows an example of the image guidance system being used toprovide a single image display (which may or may not incorporatesuperimposed data or indicia from multiple sources).

FIG. 7D an example of the image guidance system being used to provideseparate displays of multiple images.

FIG. 7E shows the human subject positioned on the operating table andwearing the head frame having fiducial anatomical markers and atransmitter thereon.

FIG. 8 is a schematic depiction of an electromagnetic field having asensor equipped working device of the present invention positionedtherein.

FIG. 8A is a perspective view of one embodiment of a localizer apparatusmountable transmitter having one or more transmitter locations.

FIG. 8B is a perspective view of another embodiment of a localizerapparatus mountable transmitter having three transmitter locations.

FIG. 8C is a perspective view of another embodiment of a localizerapparatus mountable transmitter having three transmitter locations.

FIG. 9 shows the human subject positioned on the operating table duringperformance of an image guided interventional procedures using sensorequipped device(s) of the present invention.

FIG. 9A is a schematic showing of a video monitor displaying indicia ofthe path of advancement or movement of a sensor equipped working devicein accordance with the present invention.

FIG. 10A shows a first orthogonal view of an anatomical image withindicators of the current position of the distal tip of a working deviceand indicia of the path of advancement of that working device, as seenon a video monitor screen during performance of a procedure according tothis invention.

FIG. 10B shows a second orthogonal view of the procedure shown in FIG.10A as viewed on a separate video monitor screen during performance of aprocedure according to this invention.

FIGS. 11A-11C show examples of direct line-of-sight endoscopic imageswith superimposed indicia indicating the positions of anatomicalstructure(s) and/or apparatus that are hidden from view on theline-of-sight endoscopic images, as viewed on video monitors duringperformance of procedures according to this invention.

FIG. 12 shows a sensor-equipped working device of the present inventionthat is additionally equipped with a rotation sensor to indicate therotational orientation of the device while it is positioned within asubject's body.

FIGS. 13A and 13B are schematic showings of examples of anatomicalimages viewed on a video monitor with indicia of the current positionand prior path of advancement of an image guided working device shown inrelation to a) adjacent anatomical structures and b) “keep in” and/or“keep out” zones that have been delineated to assist the operator insafely and correctly performing the procedure.

FIG. 14A is a top perspective view of a first embodiment of a fiducialmarker mouthpiece according to the present invention.

FIG. 14B is a side perspective view of the fiducial marker mouthpiece ofFIG. 14 A.

FIG. 15A is a top perspective view of a second embodiment of a fiducialmarker mouthpiece according to the present invention.

FIG. 15B is a side perspective view of the fiducial marker mouthpiece ofFIG. 15 A.

FIG. 15 C is a front view of the mouth of a human subject having thefiducial marker mouthpiece of FIGS. 15A and 15B in its operativeposition.

FIG. 16 is a partial cut-away side view of a sensor equipped guidewireof the present invention attached to a cable/connector assembly of thepresent invention.

FIG. 17 is a partial cut-away side view of a sensor equipped workingdevice of the present invention having a cable/connector assembly of thepresent invention attached thereto.

FIG. 18 is an exploded view of a system of the present invention thatincludes a tubular guide working device, an extension that is attachableto the proximal end of the tubular guide working device and a navigationelements assembly that is attachable to the extender to facilitatetracking of the working device by an IGS system.

FIG. 19 is a fully assembled view of the device of FIG. 18 along with anIGS system useable therewith.

DETAILED DESCRIPTION

The following detailed description, the drawings and the above-set-forthBrief Description of the Drawings are intended to describe some, but notnecessarily all, examples or embodiments of the invention. The contentsof this detailed description, the accompanying drawings and theabove-set-forth brief descriptions of the drawings do not limit thescope of the invention or the scope of the following claims, in any way.

In this invention, various types of working devices are equipped withsensors and are used to perform interventional procedures within theparanasal sinuses, ears, noses and throats of human or animal subjects,while an image guidance system is used to track the location of thesensor(s) and, hence, the location(s) of the working device(s). FIGS.1-6 and 11 show examples of sensor equipped working devices of thepresent invention. FIGS. 7A-17 show various components and operationalaspects of an image guidance system of the present invention and its usein conjunction with the sensor equipped working devices of the presentinvention.

FIGS. 1 and 1A show a sensor equipped guidewire 10 that may be insertedthrough a nostril (with or without a guide tube or guide catheter) andadvanced to a desired location within a paransal sinus, ear, nose orthroat. This sensor-equipped guidewire 10 comprises an elongate flexiblebody 12 having a proximal end PE and a distal end DE. As shown in thecut-away view of FIG. 1A, the elongate body 12 comprises a core member19 which may be solid or tubular. In the particular example shown, thecore member 19 is tubular and comprises stainless steel hypotube.Optionally, an outer member 18 such as a helical strand or wire may bewound or otherwise disposed about the core member 19, as is well knownin the art of guidewire manufacturing. In the particular example shown,a distal tip member 15 formed of electrically insulating material (e.g.,plastic) is received within and/or affixed to the distal end of the coremember 19 by any appropriate means such as adhesive (e.g., epoxy),mechanical innerlocking, frictional fit, etc. An electromagnetic sensor16 (e.g., an electromagnetic coil) is disposed (e.g., coiled) about themid-region of the non-conductive distal tip member 15. Optionally, anelectrically insulating cylindrical cover 17 (e.g. a plastic sheath,plastic shrink wrap, etc) may be disposed about the electromagneticsensor 16. The outer surface of such cover 17, if present, may besubstantially flush with the adjacent outer surface of the outer member18, if present, as shown in FIG. 1A. In embodiments where the comemember 19 is hollow (e.g., hypotube) sensor leads 14 may extend from theelectromagnetic sensor coil 16, through the lumen of the core member 19and to or out of the proximal end PE of the guidewire 10. In someembodiments, a connector 21 (e.g., a jack) located on the proximal endPE of the guidewire 10 may be configured to connect to a correspondingconnector 27 (e.g., a plug) located on one end of a cable 25. Aconnector 23 on the other end of the cable 25 is then connectable to animage guidance system that is programmed for use in combination withsuch guidewire, as described more fully herebelow. In some embodiments,the guidewire's proximal connector 21 may be connected to another typesof cable/connector assembly 400 as shown in FIGS. 16 and 17 anddescribed herebelow. Also, in some embodiments of devices of thisinvention, the sensor 16 may be in wireless communication with an imageguidance system, as explained more fully hereblow.

It will also be appreciated that the outer helical wire wrap 18 mayformed of wire, a plastic strand, a helically cut metal or plastic tube,or any other suitable material. It will also be appreciated that theguidewire 10 may be constructed such that at least a distal portion ofthe outer member 18 or other outer material (e.g., helically cut tube)may be made of substantially nonferromagnetic material and may extendover the sensor 16 such that the sensor is disposed within asubstantially nonferromagnetic portion of the outer member 18. Thesensor leads 14 may then extend through the outer member 18.

Furthermore, it is to be appreciated that, in this guidewire 10 or anyother sensor equipped device of the present invention, the sensor 16need not necessarily be longitudinally aligned with or disposed aboutthe longitudinal axis of the device. Rather, the sensor may be disposedtransversely within the device or in any other suitable attitude,position or alignment. For example, in a guidewire, catheter or otherdevice that has a lumen or cavity formed therein, a crossmember mayextend transversely across such lumen or cavity and the sensor 16 may bedisposed about such crossmember (e.g., an electromagnetic coil may bewound about the cross member). Such construction may allow for betterselectivity and control of the magnetic permeability of the materiallying under and/or over the sensor 16 and may allow for a more robustdesign and construction of certain devices.

Examples of commercially available image guidance systems that may bemodified and programmed for use in connection with this sensor equippedguidewire 10, as well as the other sensor equipped working devicesdescribed in this patent application, include the ENTrak Plus™ andInstaTrak ENT™ systems available from GE Medical Systems, Salt LakeCity, Utah as well as systems available from Surgical NavigationTechnologies, Inc., Louisville, Colo., Biosense-Webster, Inc., DiamondBar, Calif. and Calypso Medical Technologies, Inc., Seattle, Wash.

As described herebelow, it will often be desirable to advance cathetersor other devices over the guidewire 10 after the guidewire 10 has beeninserted into the subject's body. Thus, the guidewire body 12 and anyproximal connector 21 may be small enough in diameter to allow thedesired catheter(s) and/or other devices(s) to be advanced over theguidewire body 12 and any proximal connector 21.

FIGS. 2A and 2B show examples of sensor equipped tubular guides 20 a, 20b that may be inserted through a nostril (with or without a guidewire)and advanced to a desired location within a paranasal sinus, ear, noseor throat. All of portions of tubular guides of the present inventionmay be rigid, flexible or malleable. In the particular examples shown inFIGS. 2A and 2B, the tubular guides 20 a, 20 b are substantially rigidand preformed to a specific shape to facilitate advancement of thetubular guide 20 a or 20 b to locations that are immediately adjacent tothe ostia of paranasal sinuses such that working devices such asdilation catheters and the like may be advanced through the tubularguide 20 a or 20 b and into or through the adjacent sinus ostium.

Specifically, FIG. 2A shows an example of a tubular guide 20 a that isconfigured for use in accessing the ostium of a maxillary sinus of ahuman subject. This tubular guide 20 a comprises a substantiallystraight proximal portion 22 a and a curved distal portion 24 a. A Luerhub 28 a is mounted on the proximal end PE of the proximal portion 20 a.A sensor 16, such as an n electromagnetic sensor coil, is positioned onthe curved distal portion 24 a. Wire leads 14 may extend from theelectromagnetic sensor coil 16, though the proximal portion 22 a and outof the proximal end PE of the tubular guide 20 a, as shown, forattachment of the tubular guide 20 a to an image guidance system that isprogrammed for use in combination with such guidewire as described morefully herebelow. Although various types of construction and materialsmay be used, in this particular example, the proximal portion 22 acomprises stainless steel hypotube of approximately 0.040 inch toapproximately 0.200 inch outer diameter. It will be appreciated that inembodiments where stainless steel or other metal is used, such metalwill be separated from the sensor 16 by insulating material(s) and/orsufficient distance to avoid any affect that the meal may have on theaccuracy or function of the sensor 16. A plastic tube formed of rigidplastic (e.g., pebax, polyurethane, etc) is advanced through the lumenof the hypotube such that a portion of the plastic tube protrudes out ofand beyond the distal end of the hypotube. This protruding portion ofthe plastic tube is then plastically deformed (e.g., thermally formed)to the desired curvature, thereby forming the curved distal portion 24 aof the tubular guide 20 a. In this example, the sensor 16 comprises acoil that is wound about or positioned about the outer surface of thecurved distal portion 24 a of the tube. Optionally, a plastic film orother electrically insulating cover (e.g, an outer skin) may be heatshrunk or otherwise disposed and secured about the electromagneticsensor 16 to provide a smooth outer surface in the area where theelectromagnetic sensor 16 is mounted. The electromagnetic sensor 16 maybe mounted at or near the distal tip of the tubular guide 20 a to permitthe associated image guidance system to monitor the real time positionof the distal tip of the guide 20 a. Wire leads 14 may extend from theelectromagnetic sensor 16, through or along the distal portion 24 a,through or along the proximal portion and out of the proximal end PE ofthe tubular guide 20 a, as shown. In this regard, the plastic tube thatextends through the metal hypotube and protrudes thereform to form thecurved distal portion 14 a may have a large working lumen as well as oneor two additional lumens through which the wire leads 14 may pass.Alternatively, the wire leads 14 may pass along the outer surface of thedistal portion 24 a, the through the lumen of the hupotube, between theouter surface of the inner plastic tube and inner surface of the outerhypotube. In this particular example, the distal portion 24 a issubstantially rigid and is preformed to a curve of from approximately 70degrees through approximately 135 degrees, so as to be useable foraccessing the ostium of a maxillary sinus without requiring substantialcutting or surgical modification of the uncinate process or other normalanatomical structures within the nose. Alternatively, it will beappreciated that the distal portion 24 a may be malleable (e.g., amalleable metal, polymer or metal-polymer composite) so that theoperator may shape the distal portion 24 a as desired, depending on theparticular sinus ostium or other location to be accessed, anatomicalirregularities of the subject, etc. So long as the electromagneticsensor coil 16 is located distal to any curve(s) introduced in themalleable distal segment, the introduction of such custom made curve(s)will not require any recalibration or otherwise hamper the ability ofthe image guidance system to sense the position of the distal end of thetubular guide 20 a. In operation, this tubular guide 20 a is insertedthrough the subject's nostril, either alone, over a previously insertedguidewire or with a guidewire pre-inserted into the lumen of the tubularguide 20 a. The tubular guide 20 a is then advanced through the medialmeatus and rotated to cause the curve of the distal portion 24 a to passover the uncinate process such that the open distal end DE of thetubular guide 20 a is positioned adjacent to and in substantialalignment with the ostium of the maxillary sinus.

The tubular guide 20 b shown in FIG. 2B may be constructed and used inthe same manner as the tubular guide 20 a of FIG. 2A except that thecurved distal portion 24 b has a less severe curvature than the distalportion of the 24a of the guide shown in FIG. 2A. In this particularexample, the distal portion 24 b is substantially rigid and is preformedto a curve of from approximately 30 degrees through approximately 90degrees, thereby being useable for accessing the ostia of frontalsinuses.

It is to be appreciated that the particular curvatures and shapes of thetubular guides 20 a, 20 b shown in FIGS. 2A and 2B are merely examplesof the many shapes and configurations in which tubular guides of thepresent invention may be configured to accesses specific locationswithin the nose, paranasal sinuses, Eustacian tubes, etc. Additionally,it is to be appreciated that any of the guidewires 10, tubular guides 20a, 20 b or other working devices 30 of this invention may be steerable,bendable, malleable or capable of being articulated. FIG. 3 shows ageneric example of a sensor-equipped working device 30 of the presentinvention. This device 30 comprises an elongate shaft 32, a sensor 16, aworking element 36 and wires 14 that extend from the sensor 16 throughthe shaft 32 and out of the proximal end PE of the device 30. In someembodiments, the outer diameter of the working device 30 may be lessthan the inner diameter of a sensor-equipped tubular guide 20 a or 20 bor other tubular guide such that the working device 30 may be advancedthrough a tubular guide to a desired location where treatment is to beapplied. Additionally or alternatively, the working device 30 may have aguidewire lumen extending through or adjacent to the shaft 32 such thatthe working device 30 may be advanced over a sensor-equipped guidewire10 or other guide member to a desired location where the treatment is tobe applied. In this example, the sensor 16 comprises a coil that iswound about or positioned about the outer surface of shaft 32 a knowndistance from the distal end DE of the device 30. Provided that anybending, curving or flexing of the shaft 32 occurs proximal to thesensor 16, the spatial relationship of the sensor 16 to the distal endDE will remain constant and, thus, the position of the distal end DE ofthe device 30 may be determined and displayed on a video screen on thebasis of the sensed location of the sensor 16. In some embodiments, oneor more sensors may be positioned in known spatial relation to theworking element so as to provide the ability to determine and displaythe real time location of the working element on the basis of the sensedlocation of the sensor(s) 16. In embodiments where the sensor comprisesa wire coil, such coil may be positioned within or wound about the outersurface of the elongate shaft 32. Optionally, a plastic film or otherelectrically insulating cover (e.g, an outer skin) may be heat shrunk orotherwise disposed and secured about the sensor 16 to provide a smoothouter surface in the area where the sensor 16 is mounted. Wire leads 14may extend from the sensor 16, through the shaft 32 to facilitateconnection of the sensor 16 to an image guidance console (e.g., acomputer workstation) as described herein. Alternatively, the wire leads14 may pass along the outer surface of the shaft 32 and may be securedby adhesive, a surrounding wrap, sheath or skin, etc. These wire leads14 or the sensor 16 itself may be connected directly, indirectly throughan intervening apparatus (e.g., a cable, self-calibrating instrumentsystem or other intervening apparatus) or by wireless connection to theconsole 76 and/or computer 78. In applications where the sensor 16 roits leads 14 are connected to the console 76 and/or computer 78 by wayof a self-calibrating instrument system, such self-calibratinginstrument system may comprise a sensor-equipped distal instrumentattached to a proximal handpiece. The instrument system would beinitially calibrated by touching the sensor-equipped distal instrumentto fiducial markers. Once the instrument system was calibrated, thesensor-equipped distal instrument could be exchanged for othersensor-equipped distal instruments without requiring the user torecalibrate the instrument system. Instead, the instrument system wouldself calibrate by means of the proximal handpiece reading calibrationinformation embedded electronically in a tag on the distal instrument.

The working element 36 may be positioned at a location between theproximal end PE and distal end DE, as shown in the example of FIG. 3.Alternatively, the working element 36 may be positioned at or on thedistal end DE of the device 30, depending on the mode of action andintended use of the working element. The working element 36 may performor facilitate any type of therapeutic or diagnostic function. Examplesof working elements 36 that may be used include but are not limited to:dilators, balloons, substance injectors, needles, penetrators, cutters,debriders, microdebriders, hemostatic devices, cautery devices,cryosurgical devices, heaters, coolers, scopes, lenses, ports,endoscopes, light guides, phototherapy devices, drills, rasps, saws,etc. Some specific examples of working elements 36 and their uses in ENTprocedures are described in U.S. patent application Ser. Nos. 10/829,917entitled “Devices, Systems and Methods for Diagnosing and TreatingSinusitis and Other Disorders of the Ears, Nose and/or Throat,”10/912,578 entitled “Implantable Device and Methods for Delivering Drugsand Other Substances to Treat Sinusitis and Other Disorders,” 10/944,270entitled “Apparatus and Methods for Dilating and Modifying Ostia ofParanasal Sinuses and Other Intranasal or Paranasal Structures” and Ser.No. 11/037,548 entitled “Devices, Systems and Methods For TreatingDisorders of the Ear, Nose and Throat,” which are expressly incorporatedherein by reference.

Optionally, any working device 30 of this invention, may include a guidemember 37, such as a flexible, malleable or rigid wire or other elongatemember, that extends from the distal end DE of the device, as shown inphantom in FIG. 3. This guide member 37 may be tapered or nontapered.The guide member 37 will typically be smaller in diameter than the body32 of the working device 30 such that the guide member may be easilyadvanced through an ostium of other anatomical opening, therebyfacilitating or “guiding” placement of the body 32 of the device 30 in aposition adjacent to that ostium or opening and/or thereby facilitatingor guiding further advancement of the body 32 of the device 30 throughthat ostium or opening.

In systems used to perform FTSI procedures, a working device 30 whereinthe working element 36 comprises a balloon or other dilator will be usedto dilate the ostium of a paranasal sinus. FIGS. 4-4J show some specificexamples of sensor equipped working devices in the nature of dilationcatheters (e.g., balloon catheters) for dilation of the ostia ofparanasal sinuses or other anatomical or pathological structures.

FIGS. 4-4B show an embodiment of a sensor equipped dilation catheter 40a comprising a shaft 42 comprising a single, multi-lumen tube, aproximal Luer hub 48, a balloon 46, sensor(s) 16 and sensor leads 14.While any number of sensors 16 may be used, the example shown in FIGS.4-4B incorporates two (2) sensors 16, wherein one sensor 16 is locatednear the proximal end of the balloon 46 and the other sensor 16 islocated near the distal end of the balloon 46. A through lumen 94extends from the bore of the proximal Luer hub 48, through the shaft 42and terminates distally in a distal end opening. This through lumen 94may be used for fluid infusion/aspiration and/or for guidewire passage.Lead lumens 98 also extend through the shaft 42 and the sensor leads 14extend through such lead lumens 98. An inflation/deflation lumen 96extends from a sidearm port 49 on the proximal hub 48, through the shaft42 and terminates in an aperture 91 within the balloon 46 to facilitateinflation and deflation of the balloon 46. For applications intended todilate the ostia of paranasal sinuses, the balloon will typically beformed of a relatively non-compliant material such as polyethyleneteraphthalate (PET) or nylon of a thickness and density that renders theballoon capable of withstanding inflation pressures of up toapproximately 25 atmospheres. The balloon 46 may have a straightcylindrical side wall with tapered ends, as shown, and if the balloon 46is so constructed, the sensors 16 may be positioned directly beneath theproximal and distal ends of the straight cylindrical mid-portion MP ofthe balloon 46 as seen in FIG. 4A. As explained more fully herebelow,this catheter 40 may be advanced to a position where the deflatedballoon 46 is positioned within a stenotic ostium of a paranasal sinuswith the distal sensor 16 on one side of the ostium and the proximalsensor 16 on the other side of the ostium. The balloon 46 may then beinflated one or more times to desired pressure(s) (e.g., typicallypressures ranging from about 10 atmospheres through about 25atmospheres) to dilate the stenotic ostium. Thereafter, the balloon 46may be deflated and the dilation catheter 40 removed. FIGS. 4C and 4Dshow another way in which a sensor equipped dilation catheter 40 b maybe constructed. In this example, the catheter 40 b differs from thatshown in FIGS. 4-4B because its shaft 104 comprises an outer tube 100and an inner tube 102. The inner tube 102 extends through the outer tube100 and protrudes out of the distal end of the outer tube 100 by a fixeddistance. The sensors 16 are mounted on the outer tube 100 at spacedapart locations such that one sensor 16 is directly beneath the proximalend of the straight walled midportion MP of the balloon 46 and the othersensor 16 is directly beneath the distal end of the straight walledmidportion MP of the balloon 46. The outer tube 100 has a main throughlumen 106 and two lead lumens 108 through which the sensor leads 14extend. The inner tube 102 has a through lumen 103 which may be used asa guidewire lumen and/or an infusion/aspiration lumen or for otherpurposes. The outer diameter of the inner tube 102 is smaller than theinner diameter of the outer tube 100 such that a space exists to allowballoon inflation fluid to be infused into or removed from the balloon46 through the lumen of the outer tube 100. This embodiment of thedilation catheter 40 shown in FIGS. 4C-4D may be positioned and used todilate the ostium of a paranasal sinus in the same manner as thatdescribed above with respect to the embodiment of FIGS. 4-4B.

FIGS. 4E and 4F show yet another way in which a sensor equipped dilationcatheter 40 c may be constructed. In this example, like the exampleshown in FIGS. 4C and 4D, the catheter 40 c has a shaft 114 thatcomprises an outer tube 100 a and an inner tube 102 a, wherein the outertube 100 a terminates near the longitudinal midpoint of the balloon 46and the inner tube 102 a extends through the outer tube 100 a andprotrudes out of the distal end of the outer tube 100 a by a fixeddistance. In this embodiment of the catheter 40 c, the proximal sensor16 is positioned on the outer tube 100 a at a location that is directlybeneath the proximal end of the straight walled midportion MP of theballoon 46 and the other sensor 16 is positioned on the inner tube 102 aat a location that is directly beneath the distal end of the straightwalled midportion MP of the balloon 46. The outer tube 100 a has a mainthrough lumen 106 a and one lead lumen 120 through which the sensorleads 14 from the proximal sensor 16 extend. The inner tube 102 a has athrough lumen 103 a which may be used as a guidewire lumen and/or aninfusion/aspiration lumen. The outer diameter of the inner tube 102 a issmaller than the inner diameter of the lumen 106 a of outer tube 100 asuch that a space exists to allow balloon inflation fluid to be infusedinto or removed from the balloon 46 through the lumen 106 a of outertube 100 a.

In the example of FIGS. 4E and 4F, the sensor leads 14 from the distalsensor 16 extend along the outer surface of the inner tube 102 a, asshown, and may be secured to the outer surface of the inner tube 102 aby any suitable means such as adhesive, clips, bands, sheathing, shrinkwrapping, etc. It is to be appreciated, however, that in any of theembodiments, any of the sensor leads 14 may extend outside of, within orthrough a lumen of any portion of the catheter shaft, as may bedesirable or expedient for manufacturing or operative purposes and/or tominimize electrical interference and optimize signal transmission. Forexample, FIGS. 4G and 4H show another way in which a sensor equippeddilation catheter 40 d may be constructed. In this example, like theexample shown in FIGS. 4E and 4F, the catheter 40 d has a shaft 126 thatcomprises an outer tube 100 b and an inner tube 102 b. The outer tube100 b terminates near the longitudinal midpoint of the balloon 46 andthe inner tube 102 b extends through the outer tube 100 b and protrudesout of the distal end of the outer tube 100 b by a fixed distance.Again, in this embodiment of the catheter 40 d, the proximal sensor 16is positioned on the outer tube 100 b at a location that is directlybeneath the proximal end of the straight walled midportion MP of theballoon 46 and the other sensor 16 is positioned on the inner tube 102 bat a location that is directly beneath the distal end of the straightwalled midportion MP of the balloon 46. The outer tube 100 b has a mainthrough lumen 106 b and one lead lumen 126 through which the sensorleads 14 from the proximal sensor 16 extend. The inner tube 102 b has athrough lumen 103 b which may be used as a guidewire lumen and/or aninfusion/aspiration lumen. The outer diameter of the inner tube 102 b issmaller than the inner diameter of the outer tube 100 b such that aspace exists to allow balloon inflation fluid to be infused into orremoved from the balloon 46 through the lumen 106 b of the outer tube100 b. In this embodiment, a second lead lumen 128 is formed in the wallof the inner tube 102 b and the wire leads 14 from the distal sensor 16extend through such second lead lumen 128, as shown.

FIGS. 4I and 4J show yet another way in which a sensor equipped dilationcatheter 40 e may be constructed. In this catheter 40 e, the shaft 136comprises an outer tube 100 c that terminates within the proximal regionof the balloon 46 and the inner tube 102 c extends through the outertube 100 c such that it protrudes out of the distal end of the outertube 100 c by a fixed distance. In this embodiment, both the proximaland distal sensors 16 are positioned on the inner tube 102 c.Specifically, the proximal sensor 16 is positioned on the inner tube 100c at a location that is directly beneath the proximal end of thestraight walled midportion MP of the balloon 46 and a distal sensor 16is positioned on the inner tube 102 c at a location that is directlybeneath the distal end of the straight walled midportion MP of theballoon 46. The outer tube 100 c has a main through lumen 106 c throughwhich the inner tube 102 c extends. The inner tube 102 c has a throughlumen 103 c which may be used as a guidewire lumen and/or aninfusion/aspiration lumen and two lead lumens 142, 144 through which thesensor leads 14 from the proximal and distal sensors 16 extend. Theouter diameter of the inner tube 102 c is smaller than the innerdiameter of the lumen 106 c of outer tube 100 c such that a space existsto allow balloon inflation fluid to be infused into or removed from theballoon 46 through the lumen 106 c of outer tube 100 c.

Although the balloons 46 shown in FIGS. 4-4J are straight walledcylindrical balloons having tapered ends, it is to be appreciated thatvarious other shapes and configurations of balloons may be employed inany embodiments of the dilation catheter 40. For example, one or moredepressions or indentations (e.g., an annular depression or groove) maybe formed in the midportion MP of each balloon to facilitate positioningof the balloon and seating of ostial tissue or other anatomical tissuewithin such depressions or indentations. Examples of balloons havingsuch depressions or indentations are described in U.S. patentapplication Ser. Nos. 10/829,917, 10/944,270 and 11/037,548, which areexpressly incorporated herein by reference.

It is to be appreciated that the specific examples shown in the drawingsare merely examples. Indeed, the sensors 16 may be positioned at manyother locations other than those shown in these examples. For example,in any sensor equipped dilation catheter 40, sensor(s) may be located inthe center of the balloon 46 or other working element and/or elsewhereon or in the catheter shaft within the balloon 46 or other workingelement and/or distal to the balloon 46 or other working element and/orproximal to the balloon 46 or other dilator and/or within the wall(s) ofthe balloon 46 or other dilator.

Also, in any of the working devices having lumen(s) the shaft of thedevice (e.g., the catheter body) need not be of coaxial (e.g., tubewithin a tube) design, but alternatively may be a single catheter bodyhaving a plurality of lumens. For example, in the case of a balloondilation catheter, a catheter shaft having four lumens may be used. Onelumen may serve as a guidewire/working lumen, one lumen may serve as aballoon 46 inflation/deflation lumen and the other two lumens may serveas passageways for the sensor leads 14. Also, as stated, in any of thesensor equipped devices 10, 20, 30, 40 a fixed guide tip and/or sensor16 may be located at the distal end DE of the device.

Also, in any embodiment of a sensor equipped dilation catheter 40, theballoon 46 may be replaced by other types of dilators or expandablestructures, such as expandable mesh cages and the like.

Also, in any embodiment of a sensor equipped dilation catheter 40, theballoon 46 or other dilator may be coated, textured, equipped withinjection ports or otherwise equipped and/or constructed to deliveradditional treatment(s) in addition to the primary anatomical dilation.For example, the balloon 46 may be coated with or may comprise a drug orany other substance (e.g., a hemostatic agent or a substance that detersscarring or adhesion formation) that will transfer onto or into thetissue contacted by the balloon. Examples of balloons having suchadditional treatment delivering capabilities are described in U.S.patent application Ser. Nos. 10/912,578 and 11/037,548, which areexpressly incorporated herein by reference.

Additionally, in some embodiments of sensor equipped dilation catheter40, a stent or other radially expandable implantable device may bemounted on the exterior of the balloon 46 or other dilator such that,when the balloon 46 is inflated (or when any other type of dilator isexpanded) the stent or other radially expandable implantable device willbe expanded and will remain within the body after the balloon has beendeflated (or the other type of dilator contracted) and the dilationcatheter 40 removed. Examples of stents and other radially expandableimplantable devices that may be used in conjunction with these sensorequipped dilation catheters 40 are described in U.S. patent applicationSer. Nos. 10/829,917; 10/912,578; 10/944,270 and 11/037,548, which areexpressly incorporated herein by reference.

In some applications, it may be desirable to utilize a sensor equippedsubselective sheath 50, such as that shown in FIGS. 5 and 5A. The sheath50 shown in FIGS. 5 and 5A comprises an elongate tubular body 52 havinga Luer hub 54 on its proximal end PE and a sensor 16, such as anelectromagnetic coil located at some desired location, such as at ornear the distal end DE of the tubular body 52. A main lumen 216 extendsthrough the tubular body 52 in communication and direct alignment withthe bore of the Luer hub 54. A separate lead lumen 56 also extendsthrough the tubular body 52. Sensor lead wires 14 extend through suchlead lumen 56 and out of the proximal hub 54 such that the lead wires 14may be connected to the computer of an image guidance system asdescribed more fully herebelow. In some embodiments, the inner diameterD1 of the sheath lumen 216 will be large enough to allow a guidewire 10and/or working device 30, 40, 60 to be advanced through the lumen 216 ofthe subselective sheath 50 and/or the outer diameter D2 of the tubularbody 52 will be small enough to advance through a tubular guide 20 a, 20b. The tubular body 52 of the subselective sheath 50 may be formed of apolymer such as Pebax, polyimide, high density polyethylene (HDPE), lowdensity polyethylene (LDPE), blends of HDPE/LDPE, etc. and may have awall thickness from approximately 0.001 inches through approximately0.050 inches. In some embodiments, a lubricious liner or coating may bedisposed within the main lumen 216 to facilitate sliding of guidewiresor working devices therethrough.

Another type of sensor equipped working device of the present inventionis a penetrator 60, as shown in FIG. 6. In the example shown, thepenetrator 60 comprises a solid or hollow elongate body 62 (e.g., aplastic or stainless steel rod or hypotube of approximately 14 gagethrough approximately 27 gage having a sharp tip 64 at its distal endDE. A sensor 16, such as an electromagnetic coil, is positioned at adesired location on the penetrator, such as at or near its distal endDE. In some embodiments a sensor coil may be wrapped about the elongatebody 62. A notch or depression may be formed in the elongate body toaccommodate such coil wrap and a covering, such as a plastic coating,sleeve, shrink wrap, etc. may be disposed about the coil, therebyproviding a smooth outer surface and deterring direct contact of thesensor coil with body fluids or tissues. Sensor lead wires 14 extendthrough the elongate body 62 exiting near its proximal end PE such thatthey may be connected to the computer of an image guidance system asdescribed more fully herebelow.

Any of the sensor equipped working devices (e.g., guidewires, catheters,cannula, tubes, dilators, balloons, substance injectors, needles,penetrators, cutters, debriders, microdebriders, hemostatic devices,cautery devices, cryosurgical devices, heaters, coolers, scopes,endoscopes, light guides, phototherapy devices, drills, rasps, saws,etc.) may incorporate biocompatible outer layers or coatings oflubricious material to facilitate smooth advancement of the devicethrough the nasal anatomy, unless the inclusion of such coating wouldrender the device unusable for its intended purpose.

Also, any of the sensor equipped working devices may incorporate avibrator or other movement imparting apparatus to cause vibration,reciprocation, vacillation or other movement of the working device tofacilitate passage of the working device through tight or tortuousanatomical passages, unless the inclusion of such vibrator or othermovement imparting apparatus would render the device unusable for itsintended purpose.

Also, any of the sensor equipped working devices (e.g., guidewires,catheters, cannula, tubes, dilators, balloons, substance injectors,needles, penetrators, cutters, debriders, microdebriders, hemostaticdevices, cautery devices, cryosurgical devices, heaters, coolers,scopes, endoscopes, light guides, phototherapy devices, drills, rasps,saws, etc.) may incorporate internal guidewire lumens for over-the-wireuse or rapid exchange type guidewire lumens (e.g., tubes, split lumensor rails on that extend along a portion of the outer wall of thecatheter) to facilitate rapid device and/or guidewire exchange duringthe procedure, unless the inclusion of such guidewire lumen would renderthe working device unusable for its intended purpose. In embodimentsthat incorporate a rapid exchange guidewire lumen (e.g., tubes, splitlumens or rails on that extend along a portion of the outer wall of thecatheter) such rapid exchange guidewire lumen may have a length of fromabout 0.5 cm through about 10 cm. In some embodiments, the guidewirelumen may have a distal aperture at the distal end of the device and aproximal aperture located less than 10 cm proximal to the distalaperture. The sensor equipped working devices of the present invention(e.g., guidewires, catheters, cannula, tubes, dilators, balloons,substance injectors, needles, penetrators, cutters, debriders,microdebriders, hemostatic devices, cautery devices, cryosurgicaldevices, heaters, coolers, scopes, endoscopes, light guides,phototherapy devices, drills, rasps, saws, etc.) may be used inconjunction with an image guidance system to perform a variety of imageguided procedures for the treatment of sinusitis or other disorders ofthe paranasal sinuses, ears, nose or throat. An example of anelectromagnetic image guidance system is shown in FIGS. 7-9. This imageguidance system comprises a localizer apparatus 70 and a console 76 thatincludes a computer workstation 78 and a video monitor 80. As shown inFIGS. 7C and 7D, the video monitor 80 may be used in a single screenmode 80 a to single screen image or in split screen mode 80 b tosimultaneously display 2 or more images.

The localizer apparatus 70, which in this example comprises a headset,has positioning projections 71 that are configured to rest on or toinsert within the ear canals and on either side of the bridge of thesubject's nose such that each time the localizer apparatus 70 is worn bythe subject it will remain in the same substantially fixed positionrelative to the subject's paranasal sinuses and intranasal anatomy, evenwhen the subject's head is turned or moved about. Two or more radiopaquefiducial markers 72 are mounted at fixed locations on either side of theportion of the localizer apparatus 70 that resides over the subject'sforehead, as shown. Also, as seen in FIGS. 7E and 9, the localizerapparatus 70 is adapted to have a transmitter assembly 75 mounted at aspecific location in the center of the portion of the localizerapparatus 70 that resides over the subject's forehead. As illustrated inFIG. 8, the transmitter assembly 75 has one or more transmitterlocations or sites 73 which emit electrical signals that are sensed bythe sensor(s) 16 located on the working devices that will later beinserted into the subjects nose. In some cases, such as that shown inFIG. 8A, a single transmitter 75 a having single or plural (e.g., one,two, three or more) transmitter site(s) 73 may be used. If a singletransmitter site 73 is used, the transmitter 71 a may emit a variablesignal from the single transmitter site 73 to create a non-uniformelectromagnetic field such that the position of a single sensor 16 maybe determined within that electromagnetic field. If three (3) or moretransmitter sites 73 are used, the transmitter 75 a may emit separatesignals through each transmitter site 73 such that the location of anindividual sensor 16 may be determined by a process of triangulation,similar to the manner in which GPS technology is used to determine thepositions of objects on the earth's surface. In this regard, FIGS. 8Band 8C show alternative transmitters 75 b, 75 c, each of which has three(3) transmitter sites 73 at spaced apart locations which may be used forreal time triangulation of the position of a single electromagnetic coilsensor 16 located on a working device 10, 20 a, 20 b, 30, 40, 60, etc.These transmitters 75 a, 75 b are constructed such that the transmissionsites 73 are positioned on arm members 79 a, 79 b that emanate or extendfrom a central post 77, such arm members 75 a, 75 b being configured andpositioned so as to provided the needed signal transmission while notobstructing the surgeon's access to the operative field.

Referring to FIG. 7A, in one example of an image guided FTSI procedureof this invention, the subject is initially placed in a CT scanner Swhile wearing the localizer apparatus 70 (without the transmitter 75mounted thereon). A pre-procedure CT scan of the head is obtained usinga protocol that is compatible with the image guidance system to be used.After the pre-procedure CT scan has been completed, the CT scan data isdown-loaded onto a transfer disc 82. Also, the pre-procedure CT scan maybe used for planning of the procedure. During such planning, anatomicalstructures of interest (e.g., ostia and sinuses) may be identified andflagged, desired instrument trajectories may be plotted (e.g., thesurgeon may plan the trajectory on which a curved penetrator 60 will beadvanced to create openings in or between the ethmoid air cells) and“keep out” areas may be defined (e.g., skull base, posterior/superiorwall of sphenoid near pituitary, orbital floor, facial nerves, etc.)

As shown in FIG. 7B, before beginning the FTSI procedure, the CT scandata is uploaded from the transfer disc 82 into the computer 78 of theimage guidance system.

With reference to FIG. 7E, the localizer apparatus 70 is again placed onthe subject's head and a transmitter 75 is attached to the localizerapparatus 70. The positioning projections 71 are placed in the samelocations as during the pre-procedure CT scan, thereby ensuring that thelocalizer apparatus 70 and its fiducial markers 72 are in the samepositions relative to the subject's head as they were during thepre-procedure CT scan. The transmitter 75 is connected to the computer78. In accordance with its programming, the computer 78 then initiatesand performs a localization protocol to accomplish the “registration”process whereby the positions of the fiducial markers 72 are used tocorrelate the stored CT scan data with the subject's current bodyposition. Such localization protocol may require the physician to touchthe tip of a sensor equipped working device 30 or a non-sterile sensorequipped localization wand to each fiducial marker and signaling to thecomputer 78 when such is accomplished, thereby enabling the computer tocorrelate the current positions of each fiducial marker 72 within theelectromagnetic field with the position of that fiducial marker 72 onthe stored CT scan images.

With reference to FIG. 9, the sensor equipped tubular guide 20 may beinitially inserted into the subject's nose and the sensor lead wires 14of the tubular guide 20 connected to the console 76. The sensor equippedtubular guide 20, as well as the other sensor equipped working devices30, may be pre-calibrated at the point of manufacture. Calibrationdetails (e.g., length of instrument, position of sensor relative todistal tip, baseline output from additional sensors, etc.) may be storedin an electronically readable medium (e.g., a read-only tag) on or ineach working device 30 such that, when each working device 30 isconnected to the console 76 or a precalibrated handpiece, the computer78 will read the calibration tag and will cause the image guidancesystem to self-calibrate accordingly. The sensor(s) 16 of the tubularguide 20 receive signals from the transmitter site(s) 76 and in turnsend signals to the computer 78. The computer 78 uses such signals todetermine the position of the sensor(s) 16 and/or the position of adesired portion (e.g., the distal tip) of the tubular guide 20 withinthe patient's body. The computer 78 also causes an indicator of theposition of the sensor 16 and/or desired portion of the tubular guide 20to appear on the video monitor 80 relative to the CT scan imagedisplayed on the monitor 80. As the tubular guide 20 is advanced, thecomputer 78 will cause the displayed CT scan image to scroll from crosssection to cross section, thereby providing real time monitoring of theanatomical structures in the area of the sensor 16 and/or desiredportion of the tubular guide 20. While viewing the position indicatorand CT scan images on the monitor 80, the physician advances the tubularguide 20 to a position where its distal tip is adjacent to (and insubstantial alignment with) a sinus ostium or other structure to betreated by a working device 30.

A non-sensor equipped or sensor equipped guidewire may then be advancedthrough the tubular guide 20 into or through the sinus ostium or otherarea to be treated by the working device 30. In some cases, theguidewire may be initially inserted within the lumen of the tubularguide 20 and may be advanced along with the tubular guide 20. In othercases, the tubular guide 20 may be inserted first and the guidewire maysubsequently be advanced through the lumen of the tubular guide 20. Inthe particular example shown in FIG. 9, a sensor equipped guidewire 10is used. The sensor lead wires 14 of the sensor equipped guidewire 14are attached to the console 76 and the computer 78 performs theself-calibration in the same manner as described above. After theself-calibration for the guidewire 10 has been completed, the guidewireis advanced as the sensor(s) 16 on the guidewire 10 receive signals fromthe transmitter site(s) 76 and in turn the sensor(s) 16 send signals tothe computer 78. The computer 78 uses such signals to determine theposition of the guidewire's sensor 16 and/or a desired location on theguidewire 10 (e.g., its distal tip). The computer 78 also causes anindicator of the position of the sensor 16 and/or desired portion of theguidewire 10 to appear on the video monitor 80 relative to the CT scanimage displayed on the monitor 80. In some cases, while the tubularguide 20 and guidewire 10 are both positioned within the subject's body,the monitor 80 will display indicators of the positions of both thetubular guide 10 and guidewire 20. In other cases, once the tubularguide 20 has been advanced to its intended position, the indicator oftubular guide 20 position may be deactivated so that it no longerappears on the monitor 80 and the only device position indicatorappearing will then be that of the guidewire 10. In cases where positionindicators for two or more working devices 30 (e.g. a tubular guide 20and a guidewire 10 are simultaneously displayed on the monitor 80, theposition indicators may be color coded or otherwise made to bedistinguishable from one another. If more than one sensor-equippeddevice is placed in the anatomy, the surgeon (or system) must choosewhich device is the “master” (the device whose movement controls theposition of the cross hairs and therefore which image slices aredisplayed) and which device is the “reference” (ie, its relativeposition is displayed, but movement of this device does not move thecross hairs or change which image slices are displayed. In someapplications, it may be desirable to advance the guidewire 10 into asinus or other cavity such that the guidewire 10 becomes coiled withinthat cavity. If the body of the guidewire is radiodense, such coiling ofthe guidewire within the sinus or other cavity may be used as a means toenhance visualization of the cavity by fluoroscopy or other radiographicmeans. In this regard, it is to be appreciated that the guidewire 10could be equipped with a plurality of sensors 16, such that a primarysensor 16 is located at or near the distal tip and one or more secondarysensors are located along the shaft of the guidewire 10. The primarysensor 10 could remain active while the secondary sensors could beactuated and deactuated on demand. This would enable the physician toconfirm that a sufficient amount of the guidewire 10 has been advancedinto or past a particular anatomical location (e.g., confirm that enoughof the guidewire 10 has been advanced into and coiled within a paranasalsinus.

After the guidewire 10 has been advanced to its desired position (e.g.,where the distal portion of the guidewire 10 extends through the sinusostium or other area to be treated), the sensor equipped working device30 is inserted over the guidewire 10. In some cases, the tubular guide20 may remain in place and the sensor equipped working device 30 will beinserted over the guidewire 10 and through the tubular guide 20, asshown in the example of FIG. 9. In other cases, the tubular guide 20 maybe removed leaving the guidewire 10 in place and the working device 30may then be inserted over the guidewire 10 alone. The sensor lead wires14 of the sensor equipped working device 30 are attached to the console76. The computer 78 performs a self-calibration as described above.After the self-calibration for the sensor equipped working device 30 hasbeen completed, the sensor equipped working device 30 is advanced overthe guidewire 10. As the working device 30 is advanced, the computer 78receives signals from the transmitter site(s) 76 and sensor(s) 16 on theworking device 30. On the basis of such signals, the computer 78 willcause one or more indicator(s) of the position of the working device 30to appear on the video monitor 80 relative to the CT scan imagedisplayed on the monitor 80. While viewing the video monitor, thephysician may advance the working device 30 to a precise location withinthe body where its working element 36 is operatively positioned withinthe sinus ostium or other area to be treated. It will be appreciatedthat in some embodiments, a one or more sensor(s) 16 may be positionedon the working device 30 so as to delineate or mark the location of itsworking element 36 (e.g., sensors may be located at the proximal anddistal ends of a dilation balloon or a single sensor may be positioned aknown distance form the distal tip of a penetrator), therebyfacilitating precise positioning of the working element 36 relative tothe sinus ostium or other anatomical area to be treated by the workingelement 36. In some cases where other sensor equipped devices (e.g., thetubular guide 20 and guidewire 10) remain positioned within thesubject's body along with the working device 30, the monitor 80 maydisplay indicators of the positions of some or all of those otherdevices along with the indicator of the position of the working device30. In other cases, the position indicator(s) of the other devices maybe deactivated or caused not to be displayed on the video monitor 80 sothat only the position of the working device 30 is visible. In othercases, the position indicator for the working device 30 may be displayedsimultaneously with position indications of the other indwelling sensorequipped devices (e.g. tubular guide 20 and guidewire 10) and theposition indicators for each of the separate devices may be color codedor otherwise distinguishable from one another when viewed on the monitor80.

In some procedures, more than one working device 30 may be used.Accordingly, in such procedures, after one working device has been usedto deliver a desired treatment or portion of a treatment (e.g., aballoon used to dilate the ostium of a paranasal sinus), that firstworking device may be removed, leaving the guidewire 30 in place.Thereafter, another working device 30 may then be advanced over theguidewire 30 and used to deliver another stage of the treatment to thesame location. Or, the guidewire 10 may be moved to a different locationand another working device 30 (or even the same working device 30) maythen be used to deliver a treatment to a different treatment location.This may be repeated numerous times with various different types ofworking devices 30. For example, in some FTSI procedures, a firstworking device 30 in the form of a balloon dilation catheter 40 may beadvanced over the guidewire 10, used to dilate the ostium of a paranasalsinus and then removed, leaving the guidewire 10 in place. Thereafter, asecond working device in the form of a penetrator 60 may be advancedover the guidewire 10 into the paranasal sinus and used to puncture amucocele, mucocyst or other vesicle located on the wall of the sinus orelsewhere. The penetrator 60 may then be removed leaving the guidewire10 in place. Thereafter, another working device 30 in the form of a tubeor sheath 50 may be advanced over the guidewire 30 and used to lavage(e.g., wash out) the sinus. After the lavage is complete, the tube orsheath 50 may be removed, leaving the guidewire 10 in place, and yetanother working device in the nature of a substance eluting implantdelivery catheter may be advanced over the guidewire 10 and used toplace a substance eluting implant (e.g., a therapeutic implant asdescribed in incorporated U.S. patent application Ser. Nos. 10/829,917and 10/912,578) in or near the affected paranasal sinus. After all ofthe desired working devices 30 have been inserted and used, theguidewire 30 (and the tubular guide 20 if it remains at that point) maybe withdrawn and removed from the subject's nasal cavity.

With reference to FIGS. 9A and 13A-B, the computer 78 may be programmedto display on the video monitor 80 not only an indicator 94 of thecurrent position of a sensor equipped device 10, 20, 30, 40, 50, 60, 220but also path indicator(s) 97 (e.g., ghosts, dotted lines, etc.)indicating the prior positions (e.g., the path of advancement) of thatsensor equipped device 10, 20, 30, 40, 50, 60, 220 such that thedevice's path of advancement or retraction can be visualized on themonitor 80. Optionally, some distance measurement markings 95 (e.g.,hash marks) may also be displayed to allow the physician to easilydetermine the relative distance by which a sensor equipped device 10,20, 30, 40, 50, 60, 220 is advanced or retracted. Alternatively oradditionally, the computer 78 may optionally be programmed to displaypath indicator(s) 97 indicating a planned path of device advancementthat is intended to be followed.

Also, optionally, the computer 78 may be programmed such that, as asensor equipped device 30 is advanced or moved over a particular path,that path may be converted into a different type of indicia (e.g., asolid or color coded line) and displayed on the video monitor 80. Inthis regard, the tip of a sensor-equipped working device 30 could beadvanced, passed or swept over an anatomical surface or boundary and thecomputer 78 could then cause the monitor 80 to display an indication(e.g., a solid or colored line) delineating or demarcating thatanatomical surface or boundary. This aspect of the invention could beused, for example, to provide on the displayed video image an outline ofthe inner surface of a paranasal sinus. Also, for example, this aspectof the invention could be used intraoperatively to provide a currentimage of the shape of an anatomical structure that is being modified inthe procedure (e.g., the shape of the nasal septum during a septoplastyprocedure intended to straighten the septum). Similarly, by changing asetting on the computer, the surgeon could trace with the distal tip ofthe sensor-equipped device the boundary of anatomical structures to be“erased” from the displayed images.

It is to be appreciated that, in some procedures of the presentinvention, other types of imaging such as fluoroscopy or x-ray may beused as well as the image guidance system 76. Thus, the device so thepresent invention may include one or more radiopaque markers orradiographically visible region(s) to facilitate their use withfluoroscopy or x-ray.

Also, optionally, the computer 78 of the image guidance system may beprogrammed to accept operator input as to points or locations along apath of device advancement that should be tagged or flagged on thedisplayed image and/or on a recorded image maintained as a record of theprocedure. These tags can then be correlated with the image guidancesystem so that as the physician reviews the case on the CT, theendoscopic images are linked and being “flown through” as well.

Optionally, in some procedures, it may be desirable to also insert anendoscope 84 within the subject's body to obtain an endoscopic imagethat may be viewed separately or concurrently with the pre-procedurescan images and indicia of device position indicators 97, 97, 95provided on the video monitor 80. When so employed, the endoscope 84 mayor may not be equipped with sensor(s) 16 to allow its position to bemonitored by the image guidance system. Standard endoscopes used duringfunctional endoscopic sinus surgery (FESS) may be used for this purpose,including but not limited to the Karl Storz Hopkins II rigid scope(7210AA) and the Karl Storz Flexible Rhino-Laryngoscope (11101RP) whichare available commercially from Karl Storz Endoscopy—America, CulverCity, Calif. In cases where the endoscope 84 is equipped with one ormore sensor(s) of its own, the sensor(s) mounted on the endoscope willprovide a real time indication of the position of the endoscope 84within the subject's body. In cases where the endoscope 84 is notequipped with sensor(s) 16, another sensor equipped guidewire 10 ordevice 30 may be inserted into the endoscope 84 to provide an indicationof the endoscope's location within the body. For example, a non-sensorequipped endoscope 84, such as a flexible endoscope (e.g., Karl StorzFlexible Rhino-Laryngoscope (11101RP), Karl Storz Endoscopy—America,Culver City, Calif.), may be used and a sensor equipped guidewire 10 maybe inserted into (e.g., “parked” within) the working lumen of thatendoscope 84. In this manner, the sensor(s) 16 on the guidewire willprovide to the computer indicia of the position of the endoscope 84 asit is navigated through the anatomy. In this manner, an indicator of theposition of an endoscope 84 (or any other device into which the sensorequipped guidewire 10 may be inserted) may be displayed on the imageguidance system monitor 80, even though that endoscope 84 (or otherdevice) is not itself equipped with a sensor 16. A window or signaltransitionable region may be formed in the endoscope to allow thesensor(s) on the guidewire 10 to receive signals from the transmitter75, or the portion of the guidewire 10 on which the sensor(s) is/arelocated my protrude out of an opening in the endoscope to allow thesensor(s) on the guidewire 10 to receive signals from the transmitter75. It is to be appreciated that this procedure is useable not only withendoscopes 84, but also with any other devices into which asensor-equipped guidewire 10 may be inserted. For example, a sensorequipped guidewire 10 may be inserted into a needle and used to guidethe needle to a desired submucosal position where it is desired todeliver a substance (e.g., a drug or other therapeutic substance) orimplant.

In some procedures where an endoscope 84 is employed, the visual imageobtained from the endoscope 84 may be displayed on a monitor that isseparate from the image guidance system monitor 80 (e.g., on a separateendoscopic tower commonly used with endoscopes during FESS). In otherinstances, the endoscopic image may be displayed on the image guidancesystem monitor 80 interchangeably with the pre-procedure scan images andindicia of device position indicators 97, 97, 95 (e.g., such that thephysician may switch back and forth between a real time, line-of-sightimage provided by the endoscope 84 and the pre-procedure scan images anddevice position indicators 97, 97, 95 provided by the image guidancesystem. In other instances, the image guidance system may incorporatetwo separate monitors 80, one of which displays a real time,line-of-sight image provided by the endoscope 84 and the other of whichdisplays the pre-procedure scan images and device position indicators97, 97, 95 provided by the image guidance system. In still otherinstances, the image guidance system may incorporate a single monitor 80that is operable in split screen mode such that one portion of themonitor screen displays a real time, line-of-sight image provided by theendoscope 84 and another portion of the monitor screen displays thepre-procedure scan images and device position indicators 97, 97, 95provided by the image guidance system. In yet other instances, thecomputer 78 of the image guidance system may be programmed to combine orintegrate a real time, line-of-sight image that is received from theendoscope 84 with the stored pre-procedure scan images or with computermodels that have been derived from the pre-procedure scan images andloaded into the image guidance system computer 78.

FIGS. 10A and 10B show one example of the manner in which an endoscopicimage may be used in conjunction with CT scan images to provide uniquedisplays and images to the physician. In this example, a standard rigidendoscope is used. Typically, before the endoscope is inserted, avasoconstricting agent e.g., cocaine, ephedrine, etc.) is sprayed intothe nose. The endoscope 84 is then inserted into the nares andpositioned to view the medial meatus MM, which is an open passagewayadjacent to the middle turbinate MT. The uncinate process UP is a rigidstructure that protrudes from the lateral wall of the nose, near theanterior end of the middle turbinate, preventing the endoscope 84 fromviewing structures that lie behind the uncinate process UP. Suchstructures include the ethmoid bulla and an opening called the hiatussemilunaris as well as the ostium of the maxillary sinus which drainsinto the hiatus semilunaris. Thus, in typical FESS procedures, it isnecessary for the physician to surgically incise or remove the uncinateprocess UP in order to view or insert rigid instruments into the ethmoidbulla, hiatus semilunaris or ostium of the maxillary sinus. However, inthe example of FIG. 10A, the computer 78 of the image guidance systemhas used the stored CT scan data to integrate, into the displayedendoscopic image, an anatomical structure indicator 202 (e.g., a dottedline or other demarcation) showing the position of an anatomicalstructure of interest that is hidden from view of the endoscope 84 bythe protruding uncinate process UP and/or portions of the midalturbinate MT. In the particular example of FIG. 10A, the anatomicalstructure indicator 202 is in the form of a generally circular dottedline showing the perimeter of the maxillary sinus ostium MO. A flexiblesensor equipped working device 30 is being advanced through the medialmeatus MM, around the intact uncinate process UP and into the maxillaryostium MO, as indicated by a device position indicator 94 andadvancement path indicators 95.

As shown in FIG. 10B, in this example a separate video screen displays asagital tomographic image of the maxillary ostium MO based on thepre-procedure CT scan images that are stored in the computer 78 of theimage guidance system. The computer 78 is programmed to cause anindicator 94 b of the position of the distal end of the working device30 relative to the maxillary ostium MO. In this example the indicator 94b is a circle, but any suitable marking or demarcation may be used. Thisview shown in FIG. 10B aids the physician in advancing the distal end ofthe working device 30 through the maxillary ostium MO, without having toincise or remove the uncinate process UP.

Also, in some embodiments of the invention, the computer 78 may beprogrammed to use the distal tip of the guidewire 10 or any otherlocation on any other working device 30 as a “virtual viewpoint” fromwhich a virtual endoscopic view is created from the pre-procedure CTscan images and displayed on the monitor 80.

Also included in the present invention are systems and methods forperforming endoscopic medical or surgical procedures anywhere in thebody of a human or animal subject. For example, an endoscope 84 havingan electromagnetic sensor 16 thereon may be advanced though a portionfor the subject's body while the image guidance system computer 78receives and uses signals received from the sensor 16 on the endoscope84 to determine the position of the endoscope within the subject's body,stores endoscopic images received from the endoscope and correlates thestored endoscopic images with locations within the subject's body.Thereafter, the operator may request an endoscopic image obtained from aspecified location within the subject's body and the computer 78 maydisplay on the video monitor 84 the stored endoscopic image obtained atthe selected location. In some cases, the selected location may be thecurrent location of a working device 30 within the subject's body. Inthis regard, a working device 30 that has an electromagnetic sensor 16thereon may be positioned within the subject's body, the computer 78 maydetermine the position of the working device based on signals receivedfrom the sensor on the working device 30 and the computer 78 may displayon the video monitor a stored endoscopic image that was previouslyobtained from the current location of the working device 30. In thismanner, the operator is provided with an endoscopic image of the anatomynear the working device even though the working device may not beequipped with an endoscope. In other cases, this system and method maybe used to compare a real time endoscopic image to a previously storedendoscopic image. For example, an endoscope 84 having a sensor 16thereon may be positioned within the subject's body and used to obtain areal time endoscopic image. The computer 78 may use signals receivedfrom the sensor 16 on the endoscope 84 to determine its real timeposition and to display a real time endoscopic image obtained from theendoscope currently positioned within the body and ii) a storedendoscopic image that was previously obtained at the same location wherethe endoscope 84 is currently positioned. The real time and storedendoscopic images may be displayed side by side (e.g., on separatescreens or using a split screen on a single monitor 84. This techniquemay be used, for example, to compare a post-operative or intra-operativeendoscopic image to a previously obtained pre-operative endoscopic imagefor the purpose of assessing efficacy, changes, etc.

The computer 78 of the image guidance system may also be programmed todisplay on the image guidance system monitor 80 and/or on a separateendoscopic monitor, one or more virtual images generated from the storedCT scan data and/or the device position data received from the sensor(s)16. For example, virtual images of ostia, bones and portions of devices(e.g., inflated balloons) that are not visible on a displayed endoscopicimage. Examples of this are shown in FIGS. 11A-11C.

FIG. 11A shows an image obtained from an endoscope 84 wherein an imageguided dilation catheter 40 having a dilation balloon 46 has beenadvanced partially through an anatomical opening 209 and the balloon hasbeen inflated. In this example, the computer 78 is programmed to use theinformation received from the sensor(s) on this balloon dilationcatheter 40 to superimpose or otherwise display on the endoscopic imagea virtual image (e.g., dotted line) 208 representing the portion of theinflated balloon 46 that is hidden from actual view of the endoscope.

FIG. 11B shows an image obtained from an endoscope 84 viewing ananatomical structure AS within the body. This particular anatomicalstructure AS is made up of bone covered with mucous membrane or othersoft tissue, as is typical of structures located within the nose andparanasal sinuses. An ostium OS or opening is formed in the anatomicalstructure AS, as shown. In this example, the computer 78 is programmedto use information from the stored pre-procedure CT scan data tosuperimpose or otherwise display, on the endoscopic image, virtualimages (e.g., dotted lines) 210 showing the edges of the bones thatunderlie the anatomical structure AS and ostium OS being viewed by theendoscope 84.

FIG. 11C shows an image obtained from an endoscope 84 positioned withinthe middle meatus MM, anterior to the uncinate process UP. In thisexample, the computer 78 is programmed to use information from thestored pre-procedure CT scan data to superimpose or otherwise display,on the endoscopic image, virtual images (e.g., dotted lines) 214 showingthe maxillary ostium MO and openings into the ethmoid air cells EO,which are hidden from the endoscope's view by the uncinate process UP.The ability to view virtual images 214 of the maxillary ostium MO and/oropenings into ethmoid air cells EO may enable the physician to advanceflexible or curved devices (e.g., the guidewires, catheters, penetratorsand any other working devices 30) into or through those openings MO, EOto perform treatment procedures directed at the maxillary sinuses and/orethmoid air cells without requiring removal or surgical modification ofthe protruding uncinate process UP. An example of a procedure fordilation the maxillary ostium and/or delivering other treatment to themaxillary sinus is described above. Various other procedures may beperformed to treat or ablate the ethmoid air cells. Some examples of thetypes of procedures that may be performed to treat and/or ablate theethmoid air cells include those described in U.S. patent applicationSer. No. 11/037,548 which is incorporated herein by reference.

Also, any of the working devices 10, 20, 30, 40, 50, 60 of the presentinvention may include, in addition to one or more of the image guidancesystem sensors 16, one or more other sensors or movement indicators thatmay provide further information regarding the 3 dimensional positionand/or orientation of the device 10, 20, 30, 40, 50, 60. The types ofother sensors or movement indication apparatus that may be used include,for example, accelerometers, strain gages (for flexible instruments),pitch/roll sensors, and capacitive sensors. FIG. 12 shows one example ofa working device 220 (e.g., a guidewire, catheter, cannula, tube,dilator, balloon, substance injector, needle, penetrator, cutter,debrider, microdebrider, hemostatic device, cautery device, cryosurgicaldevice, heater, cooler, scope, endoscope, light guide, phototherapydevice, drill, rasp, saw, etc.) that comprises an elongate shaft 222, ahub member 226 located on the proximal end PE of the shaft, an imageguidance sensor 16 (e.g., an electromagnetic coil) located on the shaft222 at a known distance from its distal end DE and a working element 36(e.g., a dilator, balloon, injector, light delivery lens, endoscopiclens, cutter, opening, port, heater, cooler, probe, or other treatmentdelivering apparatus or structure). All or portion(s) of the shaft 222may be rigid, flexible or malleable. An accelerometer 228 is mounted onone side of the hub 226, as shown. This accelerometer 228 sends signalsto the computer 78 indicating rotational movement of the device 220. Thecomputer 78 is programmed to process those signals and to provide, onthe basis of those signals, an indicator of the current rotationalorientation of the device 220 within the subject's body. In operation,as the device may be inserted into the subject's nostril with a specificmaker (not shown) or structure (e.g., one or more wings 227) of thedevice 220 in specific radial orientation (e.g., such that the wings 227on the hub 226 extend vertically up and down—at the 12 o'clock and 6o'clock positions). A foot pedal or button on the console 76 may bedepressed to cause the computer 78 to identify the current position ofthe accelerometer 228 as the “zero” or starting position. Thereafter,any clockwise or counterclockwise rotation of the device 220 will causesignals to be sent from the accelerometer 228 to the computer 78 and thecomputer will cause indicia of such rotational movement of the device220 to be shown on the monitor 80 or elsewhere.

The present invention is also useable to aid the operator in maintainingthe operative instruments within predefined areas of the subject's body(e.g., “keep in zones”) and/or to avoid advancing operative instrumentsinto other predefined areas of the subject's body (e.g., “keep outzones”). Examples of this are shown in FIGS. 13A and 13B. As shown, thecomputer 78 may be programmed to display indicia (e.g., shaded andunshaded areas) demarcating keep out zones 90 and a keep in zone 92. Theintended keep in zone(s) and keep out zone(s) may be electronicallymarked on the CT scan images during the physician's pre-procedureplanning. As shown in FIG. 13A, as a sensor equipped working device 30of the present invention is advanced or moved within the keep in zone92, device position indicators 94 and path indicators 95 will appearonly within the keep in zone 92 and no alarm (e.g., visual or audiblealarm) will be provided to the operator. However, as shown in FIG. 13B,if the working device 30 is advanced or moved into either of the keepout zones 90, the device position indicator 94 will appear in the keepin zone 92 and, optionally, the computer 78 may be programmed to causean alarm (e.g., visual or audible alarm) to be provided to the operator.

In some cases, it may be possible to maintain the subject's head in asubstantially fixed position during the procedure. In those cases, thetransmitter assembly 75 need not be mounted on a localizer apparatus 70or otherwise affixed to the subject's head. Instead, in such cases, itmay be possible for just the fiducial markers 72 to be affixed to thesubject's body while the transmitter assembly 75 and fiducial markers 72may be mounted on or within the operating table, on a nearby IV pole, onor in a fluoroscopic c-arm or elsewhere near the subject's body.However, in many image guided ENT procedures (including many FTSIprocedures), it may be desirable to move or reposition the subject'shead one or more times during the procedure. Also, in cases where thesubject remains unanesthetized, it may be desirable to allow the subjectto make some voluntary head movements during the procedure. Thus, itwill often be desirable for the transmitter assembly 75 and fiducialmarkers 72 to be mounted on a localizer apparatus 70 or otherwiseaffixed to subject's body such that after the fiducial markers 72 havebeen used to perform the initial localization/registration protocol, thetransmitter sites 73 will subsequently move in fixed spatialrelationship to the subject's head. Certainly, a localizer apparatus 70as shown in FIGS. 7E and 9 may be used for this purpose. However, suchheadset may be uncomfortable for an unanesthetized subject and/or may bean unwelcome or non-sterile obstacle located near the operative fieldduring the procedure. Thus, the present invention provides other headattachment devices that may be used to attach the fiducial markers 72and transmitter(s) 75 to the subject's head during the pre-procedure CTscan and also during the procedure. In some cases these head attachmentdevices may comprise adhesive patches that contain the fiducial markers72 and to which the transmitter 75 is attachable. In other cases, amouthpiece may be used as a head affixation device. Examples of suchmouthpieces 240, 240 a are shown in FIGS. 14A-15C.

In the embodiment shown in FIGS. 14A and 14B, a dental mouthpiece 242 isformed of silicon or other plastic. This mouthpiece 242 may beconfigured based on an impression of the subject's teeth such that thepositioning of the mouthpiece 242 will be reproducible from wearing towearing. The methods for making mouthpieces 242 of this type are wellknown and such mouthpieces are sometimes worn by athletes who playcontact sports and by some individuals who tend gnash or grind theirteeth during sleep. Radiopaque fiducial markers 244, such as metalarticles, are mounted at locations on the mouthpiece 242, as shown.These fiducial markers 72 may be located on the buccal sides of themouthpiece 242 so as to be easily accessible during thelocalization/registration protocol where it may be necessary for asensor equipped device 30 or a sensor equipped wand to be touchedagainst or placed in juxtaposition to each fiducial marker 72. Atransmitter assembly 75 mounting location is provided on the mouthpiecesuch that the transmitter 75 may be attached to the mouthpiece 242 at apredetermined, reproducible position.

The embodiment 240 a shown in FIGS. 15A-15C is the same as that shown inFIGS. 14A and 14B except that it includes a transmitter mounting member244 that is attached to the front of the mouthpiece 242. The transmitterassembly 75 may be attached to this transmitter mounting member 244.Optionally, in some embodiments, a plurality of transmitter locations orsites 73 may be at spaced apart locations along the transmitter mountingmember 73 to facilitate determination (e.g., by triangulation) of theposition of a single sensor 16 positioned within the subject's ears,nose, throat or paranasal sinuses.

FIGS. 16 and 17 show examples of a cable connector assembly 400 that maybe used in connection with any of the sensor equipped devices of thepresent invention, as well a other sensor equipped devices, tofacilitate transmission of signal(s) between the sensor equipped deviceand an image guidance system, console 76 and/or computer 78. Thiscable/connector assembly 400 comprises a cable 402 one end of which isconnected to the sensor equipped device and the other end of whichterminates in a connector 402. The sensor leads 14 extend through thecable 402 to connector 404. A corresponding connector 406 is mounted onthe image guidance system console 76 or computer 78. The connectors 404,406 may comprise multi-pin connectors as shown, or any other suitabletype of connector. In some embodiments, the connectors 404, 406 maytransmit either information or signals in addition to signals from thesensor(s) mounted on the device. For example, the sensor equipped deviceand/or connector 402 may contain a PROM, memory chip or other storagemedium that holds magnetic or digitally encoded information relating tothe device (e.g., calibration information, information relating theposition of a sensor 16 to the distal end DE of the device, informationrelating the position of the sensor 16 to a working element on thedevice, information relating to the length, diameter or other sizing ofthe device, information as to the type of device (e.g., ballooncatheter, guidewire, penetrator, cutter, tubular guide, etc.) beingemployed or numerous other types of information). That other informationmay be transmitted through certain prongs, pins, channels or othercontact points in the connectors 404, 406 while the signals form thesensor(s) is/are transmitted through other prongs, pins, channels orother contact points in the connectors 404, 406. transmitted to theimage guidance system console 76 and/or computer 78 and the connectors404, 406.

With specific reference to FIG. 16, in some cases, an optional handpiece408 may be attached to the end of the cable 402 opposite the connector404. Such handpiece may perform the dual function of 1) connecting thecable 402 to the sensor equipped device and 2) providing a handpiecethat the operator may use to manipulate, torque or otherwise move thedevice. In the particular example shown in FIG. 16, the proximal end ofa sensor equipped guidewire 10 as shown in FIGS. 1-1A and describedabove, is inserted into a bore of the handpiece 408 causing theconnector 21 on the proximal end of the guidewire body 12 to engage acorresponding connector (not seen in FIG. 16) located within thehandpiece 408. In this manner, signals from the guidewire's sensor 16will travel from the guidewire 10, through cable 402, to cable connector404 and into console/computer connector 406, thereby providingcommunication between the guidewire 10 and the image guidance systemconsole 76 and/or computer 78. When it is desired to advance anotherdevice over the guidewire 10, the handpiece may be disengaged from theproximal end of the guidewire to permit such advancement of anotherdevice over the guidewire.

With specific reference to FIG. 17, in cases where the handpiece 408 isnot needed or desired, the cable 402 may be connected directly to theproximal portion of a sensor equipped device. In the particular exampleof FIG. 17, the cable 402 is attached to the proximal hub 38 of aworking device 30 that is equipped with a working element 36 and sensor16, as shown in FIG. 3 and described hereabove. The attachment of thecable 402 to the working device 30 may be permanent or disconnectable.In instances where the cable 402 is disconnectable from the device 30, aplug and jack arrangement may be used to allow the cable 402 to bevolitionally connected to and disconnected form the device 30.

In some embodiments of the invention, the image guidance components(e.g., markers and/or sensors) need not be integrated into or attachedto the device at the time of manufacture. Rather, in some embodiments,the image guidance components may be attachable to a working device(e.g., guidewire, guide catheter, balloon catheter, lavage catheter,needle, electrosurgical probe, stent delivery catheter, substanceeluting implant delivery catheter, debrider, seeker, cannula, tube,dilator, balloon, substance injector, penetrator, cutter, debrider,microdebrider, hemostatic device, cautery device, cryosurgical device,heater, cooler, scope, endoscope, phototherapy device, drill, rasp, saw,punch, forceps and laser, etc.) at the time of the procedure. Forexample, FIGS. 18-19 show an example wherein an extender 500 is attachedto the proximal end of a working device 502 and an optical navigationelement assembly 506 is attached by way of clamp 504 to the extender500. In this manner, an optical IGS system 508, such as theVectorVision® ENT image guidance system (available from BrainLAB AG,Westchester, Ill.) or LandmarX® image guidance system (available fromMedtronic Xomed Surgical Products, Inc., Jacksonville, Fla.), may beused to monitor the position of the working device within a subject'sbody.

More specifically, in the example shown in FIGS. 18 and 19, the workingdevice 502 comprises a tubular guide having a curved distal end DE, afemale Luer connector 510 on its proximal end and a lumen extendingtherethrough. This tubular guide working device 502 is similar to thetubular guides 20 a and 20 b shown in FIGS. 2A and 2B, except that thistubular guide working device 502 does not incorporate any sensor 16 orwire leads 14. Also, in this example, the extender 500 comprises asubstantially cylindrical elongate body 514 having a lumen that extendslongitudinally therethrough, a male Luer connector 516 on its distal endand a female Luer connector 518 on its proximal end. The male Luerconnector 516 on the distal end of extender 500 is connectable to thefemale Luer connector 510 on the proximal end of the tubular guideworking device 502. In this manner, the lumen of the extender 500 issubstantially continuous with the lumen of the tubular guide workingdevice 502 such that other working devices (e.g., guidewires, ballooncatheters, lavage catheters, needles, electrosurgical probes, stentdelivery catheters and substance eluting implant delivery catheters,debriders, seekers, cannulae, tubes, dilators, balloons, substanceinjectors, penetrators, cutters, debriders, microdebriders, hemostaticdevices, cautery devices, cryosurgical devices, heaters, coolers,scopes, endoscopes, phototherapy devices, drills, rasps, saws, punches,forceps and lasers, etc.) may be inserted into the proximal end PE ofthe extender 500 and advanced through the extender 500, through thetubular guide working device 502 and out of its distal end DE. Althoughthe embodiment of the invention shown in FIGS. 18 and 19 is a tubulardevice with a cylindrical wall, the extender can also be a partiallycylindrical wall or non-tubular extender. Also, the extender 500 mayperform other optional functions. For example, prior to or after theclamp 530 has been attached to the extender 500, the extender 500 may beused as a handle to facilitate grasping and control of the tubular guideworking device 502.

In the example shown, the tubular guide working device 502 has a curve520 formed near its distal end. The angle A of such curve may range from0 to about 110 degrees. Alternatively, all or part of this tubular guideworking device 502 may be made of plastically deformable or malleablematerial such that the operator may customize the shape of this device502 before or during the procedure.

Also in the example of FIGS. 18-19, the navigation element assembly 506comprises a hub member 522, a plurality of radiating arms 524 thatextend radially from the hub member 522 and a plurality of active orpassive navigation elements 526 attached to the radiating arms 524.Examples of active optical navigation elements include light emitters,such as light emitting diodes (LEDs). Examples of passive opticalnavigation elements include reflective members (e.g., spheres) thatreflect light, such as infrared light emitted from one or more infraredlight sources located in proximity to the device. The bottom end of thehub member 522 is configured to be received by or otherwise attached tothe clamp 504. In the depicted example, the bottom end of the hub member522 is received within an upstanding sleeve portion 528 of clamp 504 anda locking pin 530 is used to hold the navigation element assembly 506 insubstantially fixed rotational position relative to the clamp 504. Thebody portion 532 of clamp 504 is designed to fit upon and frictionallyengage the cylindrical body 514 of the extender 500 such that the clamp504 and navigation element assembly 506 will be firmly attached to theextender and, thus, will be held in substantially fixed positionrelative to the extender 500 and the tubular guide working device 502 towhich the extender 500 has been attached. The extender 500 in someembodiments can have features to enhance the attachment of thenavigation element assembly to the extender in substantially fixedrotational position such as knurling, indentations, etc. Onecommercially available example of a navigation element assembly 506 andclamp 504 having the general configuration shown in FIGS. 18 and 19 isthe STARLINK™ Universal Instrument Adapter manufactured by BrainLAB,Inc., Westchester, Ill.

Although FIGS. 18 and 19 show an embodiment where the navigation elementassembly 506 is attachable to and detachable from the extender 500, itis to be appreciated that, in some other embodiments of this invention,the clamp 504 and/or navigation element assembly 506 may be integratedinto or pre-attached to the extender 500. For example, a clamp or otherfitting designed to receive and attach the navigation element assembly506 may be molded into or pre-attached to the extender 500. Or, all orpart of the navigation element assembly 506 (e.g., with or withoutinclusion of the active or passive navigation elements 526) may bemolded into or pre-attached to the extender 500.

The IGS system 508 generally comprises a monitor 534 and one or morecamera(s) 538. Additionally, when the navigation elements 525 arepassive (e.g., reflective) rather than active (e.g., light emitting),the IGS system 508 may further comprise one or more light emitter(s) 536(e.g., infrared lamps) which emit light that is reflected by the passivemarkers 526. Additionally, the IGS system incorporates a computingdevice (e.g., a computer or microprocessor) that is loaded with softwarefor calibration and tracking of the distal end DE of tubular guideworking device 502 and/or other working devices within the subject'sbody. A user interface (e.g., a keypad, keyboard, touch screen, otherdata entry apparatus, etc.) may also be provided to enable the user toenter parameters or information into the system 508. In someembodiments, the computing device 540 may be programmed with softwarethat includes a database containing design parameters (e.g., length,curvature/shape, etc.) for a number of tubular guides and/or otherworking devices to which the extender 500 may be attached. In suchembodiments, the user interface device is used to enter or detect theparticular type of working device. Typically, the user enters the typeof guide device 100 (e.g. a maxillary sinus ostium access guide device)in the surgical navigation system. The software in the surgicalnavigation system then calibrates the position and/or orientation of thedistal tip of guide device 100 to navigational unit 118, and hence tothe surgical navigation system.

In typical operation, the male Luer connector on the distal end of theextender 500 is firmly attached to the female Luer connector 510 on theproximal end of the tubular guide working device 502. The navigationelement assembly 506 is attached to the clamp 504 and the clamp 504 isfirmly mounted on the extender 500, as described above. Storedanatomical images, such as CT scan images are displayed on the monitor534 of the IGS system 508. In some cases, a facemask or other headgearcontaining fiducial markers may have been worn by the subject as the CTscan images (or other anatomical images) are obtained and the locationsof the fiducial markers on the scanned images may then be used forpurposes of registration in accordance with the instructions provided bythe manufacturer of the IGS system. Examples of headgear containingfiducial markers that may be used for this purpose include those devicesshown in FIGS. 7E, 9 and 14A-15C of this application as well as thosedevices commercially available as the Reference Headband/Reference Star(BrainLAB, Inc., Westchester, Ill.) and the Framelock™ kit (MedtronicXomed Surgical Products, Inc., Jacksonville, Fla.) In other cases, thesubject may not have worn fiducial markers during the prior CT scan (orother anatomical imaging procedure) and, instead, an alternativecalibration technique may be used. For example, the position and/or thetrajectory of the distal end DE of the tubular guide working device 502may be calibrated to the surgical navigation system using an anatomicallandmark of the patient's body. To facilitate this, a device such as theZ-Touch® Registration System (BrainLAB, Inc., Westchester, Ill.) may beused. Such Z-Touch® Registration System is a special laser pointer thatallows the VectorVision® IGS system to utilize the surface anatomy ofthe subject's face and head to calculate an advanced surface-matchingalgorithm and calibrate the system to the patient's scan. Or, in anotheralternate method embodiment, the position of the distal tip of guidedevice 100 may be calibrated to the surgical navigation system using acalibration device such as VectorVision® ENT ICM4 Instrument CalibrationTool (Brainlab, Inc., Westchester, Ill.) that comprises one or morefiducial markers used for calibration purposes.

After any required calibration has been performed, the distal end DE ofthe tubular guide working device 502 may be inserted trans-nasally andadvanced to a position where the distal end DE is in alignment with oradjacent to a desired treatment sight, such as the ostium of a paranasalsinus. Thereafter, a second working device (e.g., guidewire, guidecatheter, balloon catheter, lavage catheter, needle, electrosurgicalprobe, stent delivery catheter, substance eluting implant deliverycatheter, debrider, seeker, cannula, tube, dilator, balloon, substanceinjector, penetrator, cutter, debrider, microdebrider, hemostaticdevice, cautery device, cryosurgical device, heater, cooler, scope,endoscope, phototherapy device, drill, rasp, saw, punch, forceps andlaser, etc.) may be inserted into the proximal end PE of the extender500, advanced through the lumen of the extender 500, through the lumenof the tubular guide working device 502 and out of its distal end DE tothe desired treatment location where such second working device may beused to perform a desired therapeutic or diagnostic function. One suchtherapeutic function would be to dilate an opening of a paranasal sinusby a) using the IGS system to position the distal end DE of the tubularguide working device 502 adjacent to or in alignment with the opening ofthe paranasal sinus, b) advancing a dilation catheter through theextender 500 and through the tubular guide working device 500 and intothe opening of the paranasal sinus and c) using the dilation catheter todilate the opening of the paransal sinus. Additionally or alternatively,fluids or substances may be infused through the extender 500 and throughthe tubular guide working device 502 for purposes of lavage, imaging ortreatment delivery.

FluoroCT is a relatively new technology in which a C-arm typethree-dimensional (3D) imaging device (e.g., the ISO-C3D available fromSiemens Medical Systems) is used to obtain a fluoroscopic computedtomogram. Because these C-arm devices may be mobile, Fluoro CT scans maybe obtained intraoperatively and immediately postoperatively, as well aspreoperatively. In some cases, FluoroCT may be used to obtain thepre-procedure imaging data stored in the image guidance system computer78. Additionally, in some cases, one or more FluoroCT scans may beobtained during or after the procedure and data sets from suchintraoperative or postoperative FluoroCT scans may be loaded into thecomputer 78. The computer 78 may be programmed to use such FluoroCT scandata to update the previously stored imaging data that has been obtainedby traditional CT, MRI, FluoroCT or other means, thereby adjusting thestored anatomical image data to show changes to the anatomy that haveoccurred subsequent to the pre-operative scan. Additionally oralternatively, the computer may be programmed 78 to display the newlyadded FluoroCT data in addition to or in comparison with other imagesbased on the preoperative scan, thereby allowing the surgeon to comparethe current (e.g., intraoperative or postoperative) anatomy to thepreoperative anatomy.

It is to be appreciated that the computer 78 of the image guidancesystem may be programmed with a number of optional programs (e.g.,software bundles) to provide additional or different features. Thefollowing are non-limiting examples of some of the optional capabilitiesthat may be programmed into the computer 78:

Device Path Suggestion Feature: The computer 78 may, in someembodiments, be programmed to automatically suggest path(s) ofadvancement or vector(s) along which a desired device (e.g., a sensorequipped working device 30) may be advanced to reach a desired location(e.g., the ostium of a particular paranasal sinus, the ethnoid aircells, a site of infection, a bulla, a mucocele, a mucocyst, etc.) Thesuggested path(s) of advancement or vector(s) may be selected based onoperator-input criteria (e.g., least complex path, least tortuous path,least traumatic path, safest path, etc.) After it has determined thedesired path(s) or vector(s) the computer 78 may cause indicia of suchdesired path(s) or vector(s) (e.g., dotted lines) to appear on the videomonitor 80 in relation to the displayed anatomical CT and/or endoscopicimages.

Path Ahead Mode: The computer 78 may, in some embodiments, be programmedto display not only the anatomical structures that are adjacent to ornear the current position of a sensor equipped working device 30, butalso anatomical structures that are located ahead on one or more path(s)on which the device 30 may be advanced from its current position toreach its target position. In this regard, the computer 78 may cause themonitor 80 to display 1) a tomographic section or other anatomical imageof the area in which the working device 30 is currently located (the“current location image”) and 2) one or more other tomographic sectionsor other images showing anatomical structures that lie ahead on one ormore intended path(s) of advancement (the “path ahead image(s)). Thecurrent location image and the path ahead image(s) may be displayedsimultaneously (e.g., on separate monitors, on a split screen monitor oron a single screen where with one image is inset within a larger image).Alternatively, current location image and the path ahead image(s) may bedisplayed one at a time such that the operator may switch back and forthbetween the current location image and the path ahead image(s).

Pre-Post Comparison Mode: The computer 78 may, in some embodiments, beprogrammed to take the stored pre-procedure imaging scan data andcompare it to subsequently input a post-procedural or intra-operativeimaging scan data such that the effects or anatomical changes caused bythe procedure may be assessed.

Turn Cueing Mode: The computer 78 may, in some embodiments, beprogrammed to provide a turn indicator (e.g., an audible signal orvisual indicator shown on the monitor screen) to indicate the directionthat a guidewire 10 or other sensor equipped working device 30 should beturned to navigate toward a desired target location.

Treatment Forecasting—The computer 78 may, in some embodiments, beprogrammed to utilize the stored anatomical image data (e.g., CT scandata) to provides prompts or suggestions of 1) anatomical structures orpathological lesions that may be amenable to a particular treatmentand/or 2) optimal or suggested locations and/or rotational orientationsin which working device(s) 30 may be placed in order to effect aparticular treatment and/or 3) the optimal or suggested size ordimensions of the working device(s) 30 to be used (e.g., for regionsmarked in red a 6 mm balloon diameter is suggested and for regionsmarked in blue a 7 mm balloon is suggested).

Simulation of Result—The computer 78 may, in some embodiments, beprogrammed to provide a simulated result of a particular procedurebefore the procedure is actually performed. The ability to generate asimulated result may be particularly advantageous in cases where it isnot feasible for the physician to actually view the area being treatedand, thus, is unable to make a visual assessment of such area as may beneeded to arrive at an accurate prediction of the likely therapeuticand/or untoward results of a proposed treatment or maneuver. Forexample, the console 76 and computer 78 may be adapted to receiveoperator input of the particular diameter (or otherdimensions/characteristics) of a dilator balloon that the physicianproposes to use for dilation of a particular passageway. The computer 78will be programmed with software that it will use to provide a simulatedview of what that passageway would look like after it has been dilatedby that proposed balloon and what submucosal, adjacent or hiddenanatomical structures would likely be compressed or otherwise affectedby such dilation procedure, if the procedure were actually performedusing a balloon having the proposed diameter, dimensions and/orcharacteristics.

Simulation of Device—The computer 78 may, in some embodiments, beprogrammed to provide a simulated view of a particular device that ispositioned within the subject's body. For example, the computer 78 maybe programmed with device information (e.g., the dimensions, shape andappearance of the device) and, after tracking the trajectory of a thesensor 16 mounted on that device through the anatomy, the computer 78may generate and display on the monitor 80, a “virtual” image of thedevice as it is positioned relative to the adjacent anatomy. This aspectof the invention may provide to the operator some “feel” for therelative 3 dimensional size and position of the device within the body.

Look Ahead Mode—The computer 78 may, in some embodiments, be programmedto provide a simulated view from a vantage point on a device that hasbeen inserted into the subject's body. For example, the computer 78 maycause the monitor to display a forward looking view from the distal tipof an advancing guidewire as if the operator were sitting on the distaltip of the guidewire and looking forward at the anatomy as the guidewireis advanced.

Also, it is to be appreciated that any working device 30 may incorporateendoscopic components (e.g., fiber optic light guide, fiber optic imagetransmission bundle, lenses, etc.) as well as other working elements 36.In this regard, the working device 30 may comprise an on board endoscopethat is useable to view some or all of the procedure wherein thatworking device 30 is employed. Alternatively, it is to be appreciatedthat any working device 30 may be inserted or incorporated into anendoscope such that the endoscope may be used to view some or all of theprocedure wherein that working device 30 is employed.

Also, in any device or system described herein, the locations of thesensor(s) 16 and transmitter(s) 75 or transmitter sites 73 may beswitched. For example, one or more transmitter sites 73 may be locatedon a transmitter equipped device (e.g., a guidewire, tubular guide,sheath, dilation catheter or other device having a working element asdescribed herein) and one or more sensors 16 may be located on alocalizer apparatus 70 such as a localizer frame or headset.

The use of the sensor equipped working devices 30 and methods of thepresent invention may serve a number of purposes and may provide anumber of advantages over the prior art. For example, the use of suchimage guided devices and methods may permit very precise positioning andmovement of devices within the subject's body, thereby improving thesafety of the procedure, causing less trauma or unnecessary iatrogenictissue modification, requiring less use of fluoroscopy or x-ray andhence less radiation exposure to the subject or the operator(s), etc.

It is to be further appreciated that the invention has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unsuitable for its intendeduse. All reasonable additions, deletions, modifications and alterationsare to be considered equivalents of the described examples andembodiments and are to be included within the scope of the followingclaims.

1. A method for image guided performance of a treatment procedure totreat a disease or disorder of an ear, nose, throat or a paranasal sinusin a human or animal subject using an image guidance system having anavigation element assembly that comprises a plurality of navigationelements that is useable to determine the location of the working devicewithin the ear, nose, throat or paranasal sinus of the subject on thebasis of signals received from the navigation elements of the navigationelement assembly and a working device that is useable to carry out orfacilitate at least a portion of the treatment procedure, the workingdevice having a distal end that becomes inserted into the subject's bodyand a proximal end that remains outside of the subjects body, saidmethod comprising the steps of: A) attaching an extension member to theproximal end of the working device; B) attaching the navigation elementassembly to the extension member; and C) using the image guidance systemto detect the position of the working device within the subject's bodyon the basis of signals received from the navigation elements of thenavigation element assembly.
 2. A method according to claim 1 whereinthe navigation elements comprise light emitters and wherein Step Ccomprises using the image guidance system to detect the position of theworking device within the subject's body on the basis of light emittedby the navigation elements.
 3. A method according to claim 2 wherein thenavigation elements comprise light reflectors and wherein Step Ccomprises using the image guidance system to detect the position of theworking device within the subject's body on the basis of light reflectedby the navigation elements.
 4. A method according to claim 1 wherein theworking device comprises an elongate shaft that is substantially rigid.5. A method according to claim 1 wherein the working device comprises atubular guide having a lumen through which one or more other workingdevices may be inserted.
 6. A method according to claim 1 wherein theextension member has a lumen extending therethrough and wherein Step Acomprises attaching the extension member to the proximal end of thetubular guide such that the lumen of the extension member issubstantially continuous with the lumen of the tubular guide.
 7. Amethod according to claim 1 further comprising the step of inserting asecond working device through the lumen of the extension member andthrough the lumen of the tubular guide, wherein Step B comprisesattaching the navigation element assembly to the extension member suchthat locations at which the navigation elements are positioned bearknown spatial relationships to the distal end of the working device suchthat the locations of the navigation elements detected by the imageguidance system provides a basis for determination of the location ofthe distal end of the working device within the subject's body.
 8. Asystem useable to perform a procedure in which a working device isinserted to a position within an ear, nose, throat or paranasal sinus ofa human or animal subject, said system comprising: a working device thathas a proximal end and a distal end, said working device beinginsertable into an ear, nose, throat or paranasal sinus of a human oranimal subject and useable to facilitate performance of a diagnostic ortherapeutic procedure; and an extender that is attachable to theproximal end of the working device.
 9. The system of claim 8, furthercomprising: a navigation element assembly that is attachable to or partof the extender, said navigation element assembly comprising a pluralityof active or passive navigation elements; and an image guidance systemthat is adapted to receive signals from the navigation elements and todetermine, on the basis of said signals, the current position of theworking device within the subject's body.
 10. A system according toclaim 9 wherein the navigation elements emit or reflect light andwherein the image guidance system comprises i) one or more cameras thatreceive light that has been emitted by or reflected from the navigationelements and ii) a computing device that receives signals from the atleast one camera and is programmed to use those signals to determine thelocation of the working device within the subject's body.
 11. A systemaccording to claim 8 wherein at least a portion of the working device iscurved or malleable.
 12. A system according to claim 8 wherein theworking device has a lumen extending therethrough and wherein theextender also has a lumen extending therethrough, and wherein the lumenof the extender is substantially continuous with the lumen of theworking device when the extender is connected to the working device. 13.A system according to claim 8 wherein the working device is a tubularguide.
 14. A system according to claim 9 wherein the navigation elementscomprise light emitting diodes.
 15. A system according to claim 9wherein the navigation elements comprise reflectors.
 16. A systemaccording to claim 15 wherein the system further comprises a lightemitter that emits light such that the light is reflected from thereflectors.
 17. A system according to claim 16 wherein the light emitteremits infrared light.
 18. A system according to claim 13 furthercomprising a second working device that is insertable through thetubular guide and useable to perform or facilitate the performance of adiagnostic or therapeutic procedure.
 19. A system according to claim 18wherein the second working device is selected from the group consistingof: guidewires, balloon catheters, lavage catheters, needles,electrosurgical probes, stent delivery catheters, substance elutingimplant delivery catheters, debriders, seekers, cannulae, tubes,dilators, balloons, substance injectors, penetrators, cutters,debriders, microdebriders, hemostatic devices, cautery devices,cryosurgical devices, heaters, coolers, scopes, endoscopes, phototherapydevices, drills, rasps, saws, punches, forceps and lasers.
 20. A systemaccording to claim 8 wherein the extender comprises an elongate bodysized and configured to be grasped by a human hand.
 21. A systemaccording to claim 8 further comprising a clamp for attaching thenavigation element assembly to the extender.
 22. A system according toclaim 8 wherein the extender comprises an elongate body having a lumenextending therethrough, a proximal end and a a distal end, the distalend of said elongate body having a connector thereon to facilitateconnecting the extender to the proximal end of the working device, anopening being formed in said elongate body to permit a second workingdevice or a fluid to be introduced into the lumen of the extender.
 23. Asystem according to claim 22 wherein the working device has a lumen thatis substantially continuous with the lumen of the extender when theextended is attached to the working device such that a second workingdevice or a fluid that has been introduced into the lumen of theextender may further pass through the lumen of the working device.